ML20148N211

Expresses Appreciation for Revising Schedule for Adoption of Regulations.Positive Actions Taking to Adopt Compatible Regulations within Recommended 3-yr Time Frame Ack

ML20148N211
Person / Time
Issue date:	06/20/1997
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Fletcher R MARYLAND, STATE OF
References
NUDOCS 9706260273
Download: ML20148N211 (10)

Text

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g k UNITED STATES 1.

j ij NUCLEAR REGULATORY COMMISSION l* p WASHINGTON. D.C. 3M6H001 l

g%, *****/ June 20, 1997 i

- Roland G. Fletcher, Manager l Radiological Health Program

Air and Radiation Management Administration j Maryland Department of the Environment l 2500 Broening Highway i Baltimore, MD 21224-4

Dear Mr. Fletcher:

$ Thank you for your letter of May 8,1997, that included a revised schedule for adoption of

] regulations. We acknowledge the positive actions you are taking to adopt compatible

regulations within the recommended three-year time frame. The proposed Sup?l ement 2

[ schedule for adoption, covering the Timeliness in Decommissioning rule, Sealed Source and a

Device rule, and the compatibility issues identified in NRC's February 28,1997 letter to the

! Radiological Health Program, indicates that all of the regulations will meet the three-year adoption period with the txception of the following rule, " Time!! ness in Decommissioning of Material Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 36026), which

! has an adoption date of August 15,1997. The Supplement 2 proposed adoption date is l October 1,1997. The proposed Supplement 3 schedule for the adoption of 9 other regulations, indicates that all of the regulations will meet the three year adoption period.

As requested, we have reviewed the proposed revised regulations entitled Part C Licensing i of Radioact!ve Material. Sections C.2 Definitions, C.32 (a) and (c), Expiration and I Termination of Licences and Decommissioning of Sites and Separate Buildings or Outdoor 3 Areas, C.33 Application for Renewal of Licenses, C.37 Registration of Sources or Devices j Containing Radioactive Materials, C.50 (d) Modification and Revocation of Licenses, Part D Storage and Control of Liconsed or Registered Sources of Radietion, Sections D.801 Security of Stored Source 9 of Radiation, D.1202 Notification of incidents, 0.1210 Additional Reporting Requirements for Radioactive Materials, D.1301 Vacating Premises, and Section W.108 (e), Use, Design, Performance, and Certification Criteria for Sealed Sources Used in Downhola Operations and W.305 Uranium Sinker Bars. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20, 30,32,34,35,39,40,61,70, and 71. Craig Gordon, Region I State Agreements Officer, discussed the review of the regulations with you on June 5-6,1997.

As a result of our review, we have one comment that has been identified in the enclosed chart. Please note that we have limited our review to only Division I or 11 rules or to issues that we believe affect the compatibility of your regulations. Under our current procedure, a finding that a State regulation meets the compatibility criteria of the equivalent NRC re0ulation may only be made based on a review of the final State regulation. However, we g have determined that if your proposed regulations were adopted incorporating the enclosed

, comment, and without other significant change, they would meet the compatibility criteria contained in the Office of State Programs Internal Procedure B.7. \

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Roland G. Fletcher 'JUN 2 01997 We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review.

As requested in our All Agreement State Letter SP-96-027, "Reauest to Hiahlicht Chanaes 19 Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1, 1996), please highlight the final changes and send one copy in a computer readable format, if possible.

If you have any questions regarding the comments or any of the NRC regulations used in the review, please contact me or Craig Gordon at (610) 337-5216.

Sincerely,

[ ,

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hk V Paul H. Lohaus, Deputy Director Office of State Programs

Enclosure:

As stated l

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Roland G. Fletcher MUN 2 01997 w request that when the proposed regulations are adopted and published as final regula; ions, a copy of the "as published" regulations be provided to us for review.

As requested in our All Agreement State Letter SP-96-027, "Reauest to Hiahliaht Chanaes to Aareement State Reaulations Submitted to NRC for Compatibility Review" (March 1, 1996), please highlight the final changes and send one copy in a computer readable format, if possible.

If you have any questions regarding the comments or any of the NRC regulations used in the review, please contact me or Craig Gordon at (610) 337-6216.

Sincerely,

! originalsignalBF PAULH.LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs I

Enclosure:

4 As stated i

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DATE 06/09/97* 06/06/97* 06/06/97* 06/13/97* 0630/97 OSP FILE CODE SP-AG-y SP-Min i

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i Review of Proposed Revisions to Parts C. D. and W of Maryland Regulations Against Comoatibility Djvisiend 3-and 2 Criteria

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State NRC I

& Rule Rule Subiect and Comments )

1 2 C.32 30.36 Section C.32 (eX3) does not include the numerical value "no later than 24 l l (hX2) months" as set out in Section 30.36(hX2). Under the current compatibility j

policy this rule is designated as a Division 2 matter of compatibility and

should be adopted to maintain compatibility. Under the new compatibility i

3

' policy, currently before the Commission for approval, this rule is  ;

designated as Compatibility Category D, Health and Safety (H&S). Under i the new policy, Agreement States would have to adopt the essential  !

i objective of rules designated H&S. In most cases, such essential objectives i

' would include a numerical value in a rule such as the 24 month time frame in 30.36(hX2). As such the "no later than 24 months" language will continue to be needed for compatability if the Commission approves the i new policy.

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l Date of Review: June 3,1997 Reviewer: Craig Gordon, RSAO, RI I

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l, i l Roland G. Fletcher \ t We request that when t e proposed regulations are adopted and published as final l

regulations, a copy of th "as published" regulations be provided to us for review.

As requested in our All Ag seement State Letter SP-96-027, "Reauest to Hiahlicht Chanaes to Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1, 1996), please highlight the al changes and send one copy in a computer readable format, if possible.

If you have any questions regar ing the comments or any of the NRC regulations used in the review, please contact me or Craig Gordon at (610) 337 5216.

Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs

Enclosure:

As stated l

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. J B NUCLEAR REGULATORY COMMISSION E E WASHINGTON, D.C. 20665 4 001

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Roland G. Fletcher, Manager Radiological Health Program Air and Radiation Management Administration h

Maryland Department of the Environment q

2500 Broening Highway Baltimore, MD 21224 Q $[ s

Dear Mr. Fletcher:

Thank you for your letter of May 8,1997, that included a revisc schedult for adoption of regulations. We appreciate the positive actions you are taking o adopt ccppatible regulations within the recommended three-year time frame. T e proposed Echeijc.

covering the Timaliness in Decommissioning rule, Sealed an Source and Device rule, and the compatibility issues identified in NHC's February 28,1997 letter to the Radiological

, Health Program, indicates that all of the regulations will meet the three-year adoption period with the exception of the following rule, " Timeliness in Decommissioning of Material Facilities," 10 CFR Parts 30,40, and 70 amendments W9 FR 36026), which has an adoption date of August 15,1997. The Scba . 2) proposed adoption date is October 1, 1997. The proposed h '5To'r the adoption f 9 other regulations, indicates that all of the regulations will ey oi 7xceed the thre'e ye adoption eriod, h>3 V Mx \

D4 As requested, we have reviewed the proposed' revised regulations entitled Part C Licensing of Radioactive Material, Sections C.2 Definitions, C.32 (a) and (c), Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas, C.33 Application for Renewal of Licenses, C.37 Registration of Sources or Devices Containing Radioactive Materials, C.50 (d) Modification and Revocation of Licenses, Part D Storage and Control of Licensed or Registered Sources of Radiation, Sections D.801 Security of Stored Sources of Radiation, D.1202 Notification of incidents, D.1210 Additional Reporting Requirements for Radioactive Materials, D.1301 Vacating Premises, and Section W.108 (e), Use, Design, Performance, and Certification Criteria for Scaled Sources Used in Downhole Operations and W.305 Uranium Sinker Bars. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20, 30,32,34,35,39,40,61,70, and 71. Craig Gordon, Region l State Agreements Officer, discussed the review of the regulations with you on June 5-6,1997.

As a result of our review, we have one comment that has been identified in the enclosed 1 l chart. Please note that we have limited our review to only Division I or il rules or to issues that we believe affect the compatibility of your regulations. Under our current procedure, a finding that a State regulation meets the compatibility criteria of the equivalent NRC )

regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted incorporating the enclosed ' ,

comment, and without other significant change, they would meet the compatibility criteria l contained in the Office of State Programs Internal Procedure B 7.

l l

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l Roland G. Fletcher l l

We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. 1 As requested in our All Agreement State Letter SP-96-027, "Recuest to Hiohliaht Chanaes l to Aareement State Reaulations Sub'mitted to NRC for Comoatibility Review" (March 1, 1996), please highlight the final changes and send one copy in a computer readable l l format, if possible.  ;

j If you have any questions regarding the comments or any of the NRC regulations used in l the review, please craact me or Craig Gordon at (610) 337-5216.

i i

Sincerely, I i

I l

1 Paul 'H. Lohaus, Deputy Director l Office of State Programs

Enclosure:

l As stated l

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Review of Prooosed Revisions to Parts C D, and W of Maryland Reaulations Aaainst Comoatibility Division 1 and 2 Criteria l State NRC l Qiya &lg Rule Subject and Comments 2 C.32 30.36(h)(2) Section C.32 (e)(3) does not include the numerical value "no later than 24 months" as set out in Section 30.36(h)(2). Under the current l

compatibility policy this rule is designated as a Division 2 matter of compatibility and should be adopted to ,

maintain compatibility. Under the new ~

compatibility policy, currentlylbefore this rule is designated

,ph~e o asCommissio)

Compatibility Category D, Health and 1 gpF l Safety (H&S). Under the new policy, H gf h i

Agreement States showkfr1~dopt thN essential objective of rules designated H& INhich esulelincluda a nomorieel Nc !sterthai 24 munihs is cansidared te b; ; "numeslce: ;;b;,"

which-neEdsT6'be incorporatea~into your nh tn m enu ve W aeihimy -

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Date of Review: June 3,1997 Reviewer: Craig Gordon, RSAO, RI I

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H Roland G. Fletcher l We request that when the proposed regulations a e adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review.

As redgested in our All Agreement State Letter SP-36-027, "Reauest to Hiahliaht Chanaes to Aareement State Reaulations Submitted to NRC fc>r Comoatibility Review" (March 1, 1996), pidgse highlight the final changes and send one copy in a computer readable format, if p sible.

If you have an questions regarding the comments or any of the NRC regulations used in the review, plea contact me or Craig Gordon at (610) 337-5216.

Sincerely.

Paul H. Loiwm, D< cty Director Office of State Wograms j

Enclosure:

As stated i

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S M'N MARYLAND DEPARTMENT OF THE ENVIRONMENT j- MDE g j g. g * , . - - w 21224 Parris N. Olendening Jane T. Nishida Governor GAY 8 B97 secretary e

Mr. Richard L. Bangart, Director office of States Programs j

2.,

United States Nuclear Regulatory Commission (NRC) *4 One Whiteflint -

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Rockville, MD 20852 N u)

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Dear Mr. Bangart:

ThiscorrespondencereferstotheMarylandDepartmentoftheEnvirhent (MDE) Radiological Health

• Program's (RHP) comunitment to review and improw its Regulations Adoption Plan. As part of RHP's continuing response to NRC reconsnendations from the Final Report of the September 23-27, 1996 " Integrated Materials Performance Evaluation Program" (IMPEP), an update of RHP's schedule for regulation adoption is enclosed.

Please be easured that all compatibility concerns outlined in NRC's February 28, 199~ *.etter to RHP have been fully addressed within regulation Supplement 2. Cop es of Supplement 2 were sent for review to MDE's Office of Attorney General and to Region I NRC (Craig Gordon) on, or about, May 1, 1997 v d /

7 As noted in the Regulations Adoption Management Plan dated August 30, 1996, the RHP regulations committee meets to develop, revise, and promulgate radiation regulations. Particular emphasis is given to NRC regulations that must be incorporated for compatibility within three years of issue. The first major amendment to Chapter .01, Supplement 1, became effective on December 16, 1996, ,

and published as a revision to COMAR 26.12.01.01. These " Regulations For the l

Control of Ionizing Radiation were thereby amended to incorporate Part X:

Licensing and Radiation Safety Requirements for Irradiators (58 FR 7715, July 1, l 1293).

The RHP regulation adoption management plan for 1997 is divided into several groups of amendments. NRC regulations that need to be adopted will be grouped into two more supplements, which are as follows:

Aur>olement 2 The following topics will be addressed in Supplement.2: E[ ONT l P .

l' y + "(1) Timeliness in Deconunissioning dej of VS Material Facilities (59 FR 7 pE l 36026) ; n/ Ay r// r/f 7 70

' g (2)

Sealed Source and Device Regulations Comparable to 10 CFR 30.32.g and 10 CFR 32.210; and (3) Compatibility issues' pursuant to NRC's February 28, 1997

[7A p p e^ " ) (14/ letter to RHP. g The schedule for adoption of Supp.2 is as follows:  %+ Lw79'3lH 4?w '~#s; NRC and AG review 4/30/97- 5/21/97 f/

Notice of Proposed Action 6/15/97 W ,-

Close of comment period 7/15/97 Adoption by Secretary 9/28/97 Effective date of regulations 10/1/97

Suenlement 3 The following topics will be addressed in Supplement 3

l GP-hG- pf "Together We Can Clean Up" 9 TDD POR 1HE DEAP (410) 6313009  % Pager

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(1) Preparation, Tran fGr frr Cessnercici Dictributiop, and U o of Byproduct Mat:ricl fcr Medical U30 (59 FR 6176"L, 59 FR 65243 and 60 FR 322, January 1, 1995); Odj 3 a.j .5 3 (2) Low-level Waste Shipment Manifest Information al c); 6/

and Reporting (60 FR 15649 and 60 FR 25983, March 1,1998).;

(3) rzequency of Medical Examinations for Use of Respiratory Equipment (60 PR 7900, March 13,1995) ; 2g (4) Performance Requirements f 9r )tadiography Equipment (60 FR 28323, June 30, 1995); Jy '

i (5) Radiscion Protection Requirements: Amended Definitions and Crite ria (60 FR 36038, August 14, 1995); / / + 10 (6) Medical Administration of Radiation and Radioactive Materials (60 FR 48623, October 20, 1995); Od y 3 f~

(7) Clarification of Deccounissioning Funding Re irements (60 FR i l

38235, November 24, 1995); 3 0, , / <> j 7 l

(8) Cbmpatibility with International Atomic Energy Agency (60 FR 50248 and 61 FR 28724, April 1,1996); and 7/ -

(9) Parent and Self-guarantee as an Additional Financial Mechanism -

(58 FR 68726 and 59 FR 1618, January 28, 1994). g c,/ v A 7 g 1 The schedule for adoption of Supplement 3 is as follows:

Preliminary draft complete 6/23/97 1 Internal review 5/30/97-7/9/97 i Final draft 7/24/97 NRC and AG review 7/25/97- 8/15/97 Notice of Proposed Action 9/10/97 Close of comment period 10/10/97 Adoption by Secretary 11/24/97 Effective date of regulations 12/29/97 In addition to the federally directed or initiated changes, the committee has been actively involved in other regulation amendments as follows:

1. A final draf t of proposed amendments for the revision of Chapter 3

" State Radiation Control Fund" has been completed and sent to a select group of stakeholders for comment. The stakeholders meeting was held on February 27, 1997. Turn-out was low and no major obstacles to adoption have been raised. The proposal is now being finalized for Secretary Nishida's signature. The anticipated promulgation schedule appears below:

Ccaplete AG Review 5/16/97 '

Notice of Proposed Action 6/14/97 Close of Comments l 7/14/97 '

Adoption by Secretary 7/28/97 Effective date 8/28/97

2. A Notice of Proposed Action for amendments to Chapter .02 " Inspection and Certification of Radiation Machines", necessary to renew the schedule of inspections for the x-ray machines subject to the State certification program, appeared in the Maryland Register on April 25, 1997. The comment period will l

close on May 27, 1997 and the amendments should be effective in mid July,1997 Should you have any questions concerning this letter please contact me at (410) 631-3301.

I Roland G. Fletcher, Environmental Manager Radiological Health Program cc: Craig Gordon, NRC Reg I Ann Marie DeBiase

A

'.i FEB 2 8 N4Z.

Mr. Roland G. Fletcher, Administrator Radiological Health Program Maryland Department of the Environment 2500 Broening Highway l Baltimore, MD 21224

Dear Mr. Fletcher:

I J

j We have completed a review and evaluation of the Final Maryland Rules, COMAR l

l 26.12.01.01, for compatibility with equivalent NRC regulations contained in the Code of Federal Regulations. Title 10, " Energy," Chapter I, " Nuclear Regulatory Commission, Parts 0-199. We indicated, in the Draft IMPEP Report, dated December 12,1996, that NRC staff had reviewed the 13 amendments to the final COMAR regulations adopted by the State, that became effective October 9,1995, and, based on the review, found that our i earlier comments had been addressed. However, as a result of our review for ]

compatibility, several new comments having compatibility significance were found and I have been identified in the enclosure. Therefore, we are unable to find the final Maryland  :

I regulations compatible. I As you are aware, Agreement States have flexibility to adopt rules required for compatibility in the form of legally binding requirements (LBR), as opposed to regulations, i For example, since Maryland has no welllogging licensees, comments in the enclosure

! regarding the Maryland welllogging rule can be addressed through a general LBR, such as a generic or standard license condition if an application for a welllogging license is received, if our comments need clarification, or you disagree with them, we recommend a me Tng after you have completed your review, if you have any questions regarding the comments, please contact me at (301) 415 2326 or Mr. Craig Gordon at (610) 337 5216. '

l Sincerely, OriginalSigned By:

PAUL H. LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs l

l Distribution:

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PLohaus FCameron SDroggitis PLarkins CGordon, RSAO, RI YD 7;;.

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NAME PMLarkins

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• C2/28/97

• 02/28/97

• O2/ /970

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'.' Mr. Roland G. Fletcher, Administrator Radiological Health Program Maryland Department of the Environment 2500 Broening Highway

Baltimore, MD 21224 l-

Dear Mr. Fletcher:

f We have completed a review and evaluation of the Final Maryland Rules, COMAR l 26.12.01.01,- for compatibility with equivalent NRC regulations contained in the Code 6f Federal Raoulations. Title 10, ." Energy," Chapter I,." Nuclear Regulatory Commission, Parts i 0-199. We indicated, in the Draft IMPEP Report, dated December 12,1996, that NRC staff had reviewed the 13 amendments to the final COMAR regulations adopted by the State, that became effective October 9,1995, and, based on the review, found that our earlier comments had been addressed. However, as a result of our review for compatibility, several new comments having compatibility significance were found and

- have been identified in the enclosure. Therefore, we are unable to find the final Maryland regulations compatible.

As you are aware, Agreement States have flexibility to adopt rules required for compatibility in the form of legally binding requirements (LBR), as opposed to regulations.

For example, since Maryland has no well logging licensees, comments in the enclosure ,

regarding the Maryland welllogging rule can be addressed through a general LBR, such as a generic or standard license condition if an application for a well-logging license is received, if our comments need clarification, or you disagree with them, we recommend a meeting l after you have completed your review.

If you have any questions regarding the comments, please contact me at (301) 415-2326 or Mr. Craig Gordon at (610) 337 5216.

Sincerely, l l

l 1

Paul H. Lohaus, Deputy Director I Office of State Programs Distribution:

DIR RF DCD (SP05)

RLBangart PDR (YESj_, NO__)

PLohaus FCameron SDroggitis PLarkins CGordon, RSAO, RI MD File DOCUMENT NAME: G:\PML\REGSMD2.LTR Tm ,eoehe a esy' of this desument inasete in the boa: 'C' = Copy without ettechment/ enclosure 'E' = Copy with attechment/ enclosure 'N' = No copy OFFICE - OSP~ l OSP:DD l OGC l OSP:D l l NAME PMLarkins:nb PHLohaus FCameron RLBangart DATE 02/27/97

• 02/28/97

• 02/28/97

• 02/ /970 i

• See Previous Concurrence. OSP FILE CODE:

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l DATED: FEBRUARY 28,1997 SIGNED BY: PAUL H. LOHAUS Mr. Roland G. Fletcher, Administrator Radiological Health Program Maryland Department of the Environment 2500 Broening Highway Baltimore, MD 21224 '

Dear Mr. Fletcher:

i We have completed a review and evaluation of the Final Maryland Rules, COMAR l l 26.12.01.01, for compatibility with equivalent NRC regulations contained in the Code of {

i Federal Reaulations, Title 10, " Energy," Chapter I, " Nuclear Regulatory Commission, Parts i I O-199. We indicated, in the Draft IMPEP Report, dated December 12,1996, that NRC

staff had reviewed the 13 amendments to the final COMAR regulations adopted by the l State, that became effective October 9,1995, and, based on the review, found that our j earlier comments had been addressed. However, as a result of our review for

'; compatibility, several new comments having compatibility significance were found and have been identified in the enclosure. Therefore, we are unable to find the final Maryland regulations compatible, f

As you are aware, Agreement States have flexibility to adopt rules required for compatibility in the form of legrily binding requirements (LBR), as opposed to regulations.

For example, since Maryland has no well logging licensees, comments in the enclosure l regarding the Maryland welllogging rule can be addressed through a general LBR, such as a j l

! generic or standard license condition if an application for a well-logging license is received. l l If our comments need clarification, or you disagree with them, we recommend a meeting l after you have completed your review.

l If you have any questions regarding the comments, please contact me at (301) 415-2326 i or Mr. Craig Gordon at (610) 337-5216.

Sincerely, ,

1 Paul H. Lohaus, Deputy Director ,

Office of State Programs  ;

i

Enclosure:

I As stated l 1

. . . ~ . _ . _ . .- . ._. m __ _ _ . _ _ . - .__ _. . _.

lI 4

'l Review of COMAR 28.12.01.01 Aaainst Comoatibilitv Division 1 and 2 Reauirements State NRC 6

[ h Rule Bulg_ Subiect and Comments 1 D.703 20.1703 Use of Individual Respiratory Protection Equipment.

Section D.703 a.vi. uses the words "the licensee shall use equipment within the equipment manufacturer's expressed limitations for type and mode..." Reference only to the manufacturer's limitations may narrow the scope of the rule. This narrowing may inadvertently result in a licensee failing to comply with limitations established by NIOSH or MSHA, especially if those limitations are not included (for any reason) in the ,

manufacturer's literature. This rule is a Division 1 matter I

of compatibility. We suggest that Maryland use the more general wording set out in Section 20.1703(a)(6),

which would encompass both the manufacturer's and any NIOSH or MSHA limitations.

2 D.801 20.1801 Security of Stored Material.

Section D.801 does not include the entire phrase  !

"...shall secure from unauthorized removal or access..."

as set out in Section 20.1801. The words "or access" have been deleted. This section, es written, may not require an equivalent level of security. For example, the l rule may not cover a situation where an unauthorized '

individual gained access to a storage location and removed radioactive material fro.m it's I shielding / packaging, but did not physically remove the material from the storage location. This rule is a Division 2 matter of compatibility. We suggest you amend this section to include the additional wording, "or access".

1 D.1202 20.2202 Notificction of Incidents.

In order to assure compatibility in subsections a.i.(3) and b.i.(3), the phrase "or a total organ dose A Mg>

t equivalent" should be deleted. In subsection a.ii, the word " occupational" should be deleted. M {} '

2 None 30.50 Reporting Requirements.

Staff was unable to find incident reporting requirements equivalent to those contained in i 30.50 in the

! EXHIBIT 2. Regulation Review Comments Provided to the Agreement State

. - . _ _. . - ~ --

o O*

l' State NRC Dit Bula Bula Subiect and Comments

, Maryland regulations. This rule is designated as a l Division 2 matter of compatibility and should be adopted to maintain compatibility.

2 None 39.49 Uranium Sinker Bars.

Staff was unable to find an equivalent section in the Maryland regulations. This rule is designated as a Division 2 matter of compatibility and should be adopted to maintain compatibility.

2 None 39.51 Use of Sealed Source in Well Without Surface Casing.

Staff was unable to find an equivalent section in the Maryland regulations. If Maryland has other requirements that would preclude well logging from being performed in an uncased well, staff sees no need for Maryland to adopt this requirement. However, these provisions are designated as a Division 2 matter of compatibility. Therefore,if welllogging operations could be performed in wells without surface casing, the provisions of this section should be adopted to maintain compatibility.

i t

PART C LICENSING OF RADIOACTIVE MATERIAL Sec. C.1 Pumose and Scone.

(a) This pan, and Parts G and T, of these regulations, provide for the licensing of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized pursuant to this part or Parts G or T, of these regulations, or as othenvise provided in these pans.

(b) In addition to the requirements of this part, all licensees are subject to the requirements of Parts A, D, J, and T of these regulations. Funhermore, licensees engaged in industrial radiographic operations are subject to the requirements of Part E of these regulations.

Licensees using radionuclides in the healing arts are subject to the requirements of Pan G of these regulations, and licensees engaged in wireline and subsurface tracer studies are subject to the requirements of Part W of these regulations.

Sec. C.2 Definitions.

"Princi al,activit s.," ps u d in this' ~ ~ m as' ac ivijes authorized by the' license are essOntial to aieving e purno e during wh ch no icensed materi israccessed Sto.rahntal cid to accontamina non or w ich t}iefor :icense use or d: was issued or amend.edvhich decommissiomng ketivities,osalnot are andpnncipa activities [ -

geserved:

1 Exemptions from the Regulatory Requirements l Sec. C.3 Source Material.

(a) Any person is exempt from this part to the extent that such person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1 percent (0.05 percent) of l the mixture, compound, solution, or alloy.

• I (b) Any person is exempt from this pan to the extent that such person receives, possesses, uses, or transfers unrelmed and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.

(c) Any person is exempt from this pan to the extent that such person receives, possesses, uses, or transfers:

(1) any quantities of thorium contained in (i) incandescent gas mantles, (ii) vacuum tubes, (iii) welding rods, l

Cl Supp.2

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[*.,.., ,

l

( .

1

i. l l

PART C '

l LICENSING OF RADIOACTIVE MATERIAL l Sec. C.1 Pumose and Scone.

(a) This pan, and Parts G and T, of these regulations, provide for the licensing of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized pursuant to this part or Parts G or T, of these ,

regulations, or as othenvise provided in these parts.

l (b) In addition to the requirements of this part, all licensees are subject to the requirements of Parts A, D, J, and T of these regulations. Funhermore, licensees engaged in industrial radiographic operations are subject to the requirements of Part E of these regulations.  !

Licensees using radionuclides in the healing ans are subject to the requirements of Part G of these regulations, and licensees engaged in wireline and subsurface tracer studies are subject to the requirements of Pan W of these regulations.

Sec. C.2 Definitions.

~

"Princi al activiti i,"f;ts u ~ ' mei ~ ~ jes^auttidrizsd bylhe licen ~ hich are essOntial to ackievmg e purno ich t 15 acces thed usein"this'Stogige or d and activi les gurmg icense was.tssued or amen

---

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[ wh InClocuta Rc:, creed.10 GeContamination"*

Exem; Sec. C.3 Source Material. q g pp 4 (a) Any person is exempt frc uses, owns, or transfers sourc l alloy in which the source mal the mixture, compound, solut

\(P--EDL) h)E yEQ (b) Any person is exempt fr uses, or transfers unrefined a except as authorized in a spe (g ( '

g Mo^ -

(c) Any person is exempt f uses, or transfers: l l

(1) ' any quantities of tiiorium contained in l (i) incandescent gas mantles, ]

(ii) vacuum tubes,

! (iii) welding rods, 1

Cl Supp.2 P

(iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thonum, l (v) permicidal lam as, suntamps, and lamps for outdoor or industrial lighting provided that each amp does not contain more than 2 grams of thorium,

. (vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these, or -

(vii) personnel neutron' dosimeters, provided that each dosimeter does not contain more than 50 milligmms of thorium; l (2) source material contained in the following products:

(i) glazed ceramic tableware, provided that the glaze contains not more than 20 percent by weight source material, 1

l ., (ii) glassware containing not more than 10 percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic l tile, or other glass or ceramic used in constmetion, (iii) glass enamel or glass enamel frit containing not more than 10 percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States,- before July 25,1983, or l (iv) piezoelectric ceramic containing not more than 2 percent by weight source material; (3) photographic film, negatives, and prints containing uranium or thorium; (4) any finished product or part fabricated of, or containing, tungsten-thorium or magnesium thorium alloys, provided that the thorium content of the alloy does not exceed 4 percent by weight and that this exemption shall not be deemed to authorize i

the chemical, physical, or metallurgical treatment or processing of any such product or part; (5) uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that

- (i) the counterweights are manufactured in accordance with a specific license i: sued by the U.S. Nuclear Regulatory Commission, authorizing distribution by the licensee pursuant to 10 CFR Part 40, i

e

{

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. ~. .. . - - -. - - - - - . - . . - . .- .-. . ~ . . .

(3) an afnliate (as that term is denned in i1 U.S.C.101(2)) of the licensee.

(f) The notification specined in C.31(e) shall indicate the bankruptcy court in which the petition l for bankruptcy was Gled, a copy of the bankruptcy petition, and the date of the niing of the l petition.

.Sec. C. 32 Exoiration and Termination of Licenses isod Dscommission.ingi>f3 Sitesjahd Ssparati Buildings or. Outdoor l Area $ (See also D.1301 " Vacating Premises.").

(a); ; Exeeptfas providedlin Md[ Code Asin.dStste'G6v't;Sec010 7226;(1996)l"-

(a) Execp: n; provided .a Tit!c 10, Gavern:nca: Procedurc;, See:ica 10 401 "Prc:cetica frem .

e*tsratica of license.", and provided that the licensee is applying for the same activities as allowed in the current license, each specific license expires at the end of the day, in the month and year stated in the license.

(b) , No less than 30 days before expiration of a license, the licensee shall notify the Agency promptly, in writing, and request termination of the license when the licensee decides to terminate all activities involving materials authorized under the license.;

(c) 3Within (60 'daysTof; the"oE6srrencbToff any7hffths Tfoll6wingZssahilicEnse6Tshsliipr6 vide n6tification toihe Agency. in writing /as specified in subsectibds (d) andl.(e)(1)(i)f(ii)~ brlby; license conditions , of sucli' occurrence l dsi'eitlier bsgin~ decommissioning 'ils' site /br:'anylset iarate bnilding

~

or outdoor area that sontains'residuk!' radioactivity sa thst the building drl outdoor.~akea is suitable for release in ace 6rdance with%gesey requirements!orisabmii!within/12im6nihs"of notificatihn afdecommissioninfplAdhiifsregnitedi6 j(subs 0Mtiohl(e)(l@fdhi.s(sesti6ndahdibesin decommissioning ijponfapproval;6f that plan ~if;

~

(1)fThe'lidense hasfexplisd pursuantito subsection ~(a);of this"ss6tidn?[bf (2); [The licensee hafdecidsd 16 perman6ntijTcease pri6cipal~adtivitiesiss defined in this

~

partf at.the estire sits lor[in any ' separate bnilding1drioutdo6r area thatlbontains residsal radioactivitp such' that the bnildinglor outdoor area lis;dnsuisable for:'re' ldsse in accordance with Agency requirements [or (3); IN6 E6nductsdiforrafperiodlbf 24 niontid.. or ~)._rincip_al. jaitivities under;theilicenss haWbeen; (4);i N65rinbiial?s61iVitiss~hsysjbeEn~cbiiddEisd7f6r l sF p stidFofl2Cnichthsiin?an9 sdparate or. outdoor area bhildingnbutdoo'r a'rea'tist is.tmssitAble for reldaseLin, adcord$nce

'contains with Ajehey residuil radhailivit requilrernents.

~

(d) If a licsnsee does'nof'subidit'an application f6tLli6siise~fenewal sadefCl33; Thh notinca:ica

and re ;ues: for ter:ninatica of the license .:.us: .nclude the reper: and infor:na::ca speci5ed4n paragraph: (c)(1)(iv) and (v) cf thi; acc:!cn and a plan for ec:npletica of decon.:nissioning if C- W

l 4

required by p=;;;raph (c)(2) of thi: :;=:!;n = by !!=;= ccadi:ica;.

(c) If a !!=== d= ; nc: .,;ta. : :: pp!!=:!c; fr !!==c rc==! ;;&r C.24, the licensee shall on or before the expiration date specified in the license l (1) terminate use of radioactive material; 1

l .

(2) properly dispose of radioactive material and submit a report that certifies information concerning the disposition of radioactive materials; and i (3) conduct an appropriate radiation survey, as determined by the agency, of the premises where the licensed activities were carried out and submit a report of the results of this

s. survey, unless the licensee demonstrates that the premises are suitable for release for

{

unrestricted use in some other manner. The licensee shall, as appropriate- 1 (i) report levels of radiation in units of microrads per hour of beta and gamma radiation at one centimeter and gamma radiation at one meter from surfaces, and report levels of radioactivity, including alpha, in units of disintegrations per minute (or microcuries) per 100 square centimeters removable and fixed for surfaces, microcuries per milliliter for water, and picoeuries per gram for solids such as soils or concrete; and (ii) specify the survey instrument (s) used and certify that each instrument is properly calibrated and tested.

(1) Prior to final closure of the ' facility, the licensee shall submit a (e)h<A decommissioning plan that describes the actions necessary to carry out the final

, closure, if such plan has not been previously approved by the Agency. The proposed deconunissioning plan shall include:

(i) A description of planned decommissioning activities; (ii) A description of methods used to assure protection of workers and the envirotunent against radiation hazards during decommissioning; (iii) A description of the planned final radiation survey; and (iv) An updated detailed cost estimate for decommissioning, comparison of that j estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequate funds for completion of decommissioning.

. (2) The decommissioning plan shall provide that procedures, or amendments to procedures shall not be carried out prior to approval by the Agency:

(i) Where procedures are employed that would involve techniques not applied routinely during cleanup or maintenance operations; or l (ii) Where workers would be entering areas not normally occupied where surface C49 Supp.2

. . _. ~ _ .._ . __ __ _ . _ _ _ _ _ . _.._ __

?

i e contamination and radiation levels are significantly higher than routinely L, encountered during operation; or i

i

{ (iii) Where procedures could result in significantly greater airborne concentrations

! of radioactive materials than are present during operation; or

( (iv) Where procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(3) The proposed decommissioning plan will be approved by the Agency if the information therein demonstrates that the decommissioning will be completed as soon as is reasonable M (as determined by the Agency) and that the health and safety of workers and the public will

. .0 be adequately protected. -

(4) Upon approval of the decommissioning plan by the Agency, the licensee shall complete decommissioning in accordance with the approved plan. As a final step in decommissioning,Tthe lidehseelshallTsisin'submitithe7infoMationiquijsdlin.jaisagraph

~

(e)(1)Tof thisi sectionind[shalliccrtiff[theldispo.shidn L6fJaccuniulatedl: wastes from  !

decommissioning (f) ' If/ the D infrirmati60 subinittsdJ nade^r766sidli6hT(6)f6fEthisischt'i6Edoei[nogsde46stely demonstrate that the premises are suitable for releas.e; for unrestridted use, $c !!censec ;ha!! again sub::..: ic .nfermatica mquired in pamgmph (c)(1)(v) cf 6;; sec:icn and sha!! cer:ify the ,

dispositica of acca.nulated wa;;c; from decem:ni;;ioning. I l

(e) If Sc .nfor:na:ica subn..::cd nder pamgaph; (c)'1)(v) ( er (c)(3) cf Si; ace:ica dec; ac:

adequ :cly demonstra:c mat the prc:nise; arc ;;2;b!c for release fer unre;;rie:cd use, the Agency will inform the licensee of the appropriate further actions required for termination of license.

(g) (0- Each specific license continues in effee beyond the expiration date if necessary, with respect  !

to possession of residual radioactive material present as contamination, until the Agency notifies l

1 the licensee in writing that the license is terminated. During this time, the licensee shall:

l (1) Limit actions involving radioactive material to those related to decommissioning; and l l (2) Continue to control entry to restricted areas until they are suitable for release for l unrestricted use and the Agency notifies the licensee in writing that the license is l I terminated.

(h) -(g}- Specific licenses will be terminated by written notice to the licensee when the Agency

determines that:

l l l (1) Radioactive material has been properly disposed of; (2) Reasonable effort (as determined by tte Agency) has been made to eliminate residual I

radioactive contamination if present; and (3) (i) A radiation survey has been performed which demonstrates that the premises i Supp.2 C50 e

e c-

. - . - - .- _ - - - - - -_= -. . - . . - . . - . - - -.- - _. . .- . . - - -

are suitable for release for unrestricted use; or (ii) Other information submitted by the licensee is sufficient to demonstrate that the  ;

premises are suitable for release for unrestricted use. '

Sec. C.33 "Anoticati6n foF RGWal'of Licenses; -

1 l

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~

i l Subject to Sectidri C.32(a);isn applicalidn f6rirenewal'of a specifi6 license inust be filed ~

i on a fonn; prescribed bp[the[Wghnkdih;ac^cordance with;Section C.24T ~ j

! 33 Rexreed.

Sec. C.34 Amendment of Licenses at Reauest of Licensee.

Applications for amendment of a license shall be filed in accordance with C.24 and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.

Sec. C.35 Acency Action on Aeolications to Renew or Amend. In considering an application by a licensee to renew or amend the license, the Agency will apply the criteria set forth in C.25, C.26, C.27, and C.28 and in Parts E, G, or W of these regulations, as applicable.

Seci C. 36 Person Possessine a License for Medical Use of Radioactive Material on Effective Date of These Reculations. Any person or institution possessing a specific license for the medical use of radioactive material issued prior to October 9,1995 when the licensee was authorized according to Groups I through VI of Schedule C, Part C, shall be deemed to possess a license issued under the revised regulations, according to Part G. The existing license will be valid until its stated expiration date and the renewal will be issued in accordance with the regulations dated October 9,1995.

Sec. C.37 *R'eniijsti66^6f S6d'6Fier r DivitgiC6hsinide~ Ridi6adtNE Matsiists'.

(a)_ Any.inansfsbluFeEbE;isitial~disifibbtdidf's~sshied s6df66^of~dsVi5Fb6ntsisinisiealed source 7

whose predsstTis intehded foFussndefa specific opigsneral licensFmapLssbmit a request to'the A

' gency for evsibition of adiationisafeMinf6sination aboutlits p{6 dust lsnd fonit?s? registration; gD ..

equ g . g_ ;_ g .

g . g; .

g y . .. _ _ _

the designgmanufacturesprototype; test,. .mg,Jquality contiol program,:labelini/ proposed.uses and IesictestingIAndEforisTdesieedtbebequestfinuit?Als61includA$s6ffi$ient0information al$oht installation to_ providstreasonible lserside aixlfmiistanancefoperstiniakliafetp/linsiidctionsfidd assuranceltsEthOsdiatishissfeip propsities2dflthA s6ures;or: device ^are

~~

adequate}idprotselhsilthAdijni,nunize'd$de.r$1]f(Andjiopirtyj ~~~

i (c) The%gsnEp{ih66hally^5Vsisatsi~s7sesled16tifcel6 ac6epted'indusltr istandardiMIf.thssejstsndEd(And[criteris do not! read _ilyLaphipiid irs 7devicsinsinfiradia aIparticular formulitesisisondble standards and crithia with tlis help 0f the manUfactursr'or caseithe distributofGTh~e agency l/AsenefJ$all bsel criteria andistAndsdissffidieintjole safety properties oQhe dejic'e,orisealed,sourde^are adequite io protect health and minimize danger to life andpoperty) -

C51 Supp.2

, . _.m- _-,.,._m  % ,,y _y , . . . _ . , , . - .-, .

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(d)4After completion of the eyhhiationsthelgency iss6es slsertificate of rsgistration to the pers65 making the reques'tf Thelcenificale of registration'acknowlddges ths availability.of the submitted information for inclusion in an application for a specific license' proposing,uselof the pr6dued (e) {The person sulimit_ ting'the rehseM foQvaluationlhnd registiation%f ssfety]nfonnation'hbout the product shall manufacture and distribute _ the; product in'accordance withi (1) The statements a'nd representhtiossincludidg}qsality r control piogramfcontained iriths request;;and 1

(2) ~ The provisions lof the registration'certifichte; Sec. C.38 - C.39 Ressrved 37 C.39 R=crveA Transfer of Material Sec. C.40 Transfer of Material.

1 (a) No licensee shall transfer radioactive material except as authorized pursuant to C.40, l l

(b) Except as otherwise provided in his license and subject to the provisions of C.40(c) and (d),

any licensee may transfer radioactive material:

(1) to the Agency; "

(2) to the U.S. Department of Energy; (3) to any person exempt from these regulations to the extent pennitted under such exemption; (4) to any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Agency, the U.S. Nuclear Regulatory Commission, any Agreement State or any Licensing State, or to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Agency, an Agreement State, or a Licensing State; or (5) as otherwise authorized by the Agency in writing.

l

" A licensee may transfer material to the Agency only after j receiving prior written approval from the Agency.

Supp.2 C52

(c) Before transferring radioactive material to a specific licensee of the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, or to a general licensee who is required to register with the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

(d) Any of the following methods for the verification required by C.40(c) is acceptable:

(1) The transferor may possess and read a current copy of the transferee's specine license or registration certificate.

(2) The transferor may possess a written certi6 cation by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certi5cate number, issuing agency, and expiration date.

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

(4) The transferor may obtain other information compiled by a reporting service from ofGcial records of the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State regarding the identity oflicensees and the scope and expiration dates of licenses and registration.

~

(5) When none of the methods of verification described in C.40(d)(1) through (4) are readily available or when a transferor desires to verify that informatio6 received by one of such methods is correct or up-to-date, the transferor may obtain and record con 6rmation from the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State, or a Licensing State that the transferee is licensed to receive the radioactive material.

(c) Shipment and transport of radioactive material shall be in accordance with the provisions of Part T of these regulations.

Sec. C.41 - C.49 Reserved.

ModiGcation and Revocation of Licenses Sec. C.50 Modification and Revocation of Licenses.

(a) The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspen'ded or revoked by reason of amendments to the Act, or C53 Supp.2

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l (b) Any license may be revoked, suspended, or modified, in whole or in part, for any matetial

. false statement in the application or any statement of fact required under provisions of the Act. or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any rule, regulation, or order of the Agency.

(c) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.

(d)iEach sii scific licsiseidVoksd bysth~s'niendy[eipiies^anhs]nd'6f thidsy[6n;thEilsts'6f thi Agency's : final; detsrminstionj to9 evoke lthe: lice lnseh or[oni thlelexpiration[dals (s'tatedjin [the determination,jor as othefwiss provided.bylAgencpyrder; Sec. C.51 - C.89 Reserved.

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t the basis of reliable test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of ust,.

j iii .

The licensee shall implement and maintain a respiratory protection program that i includes:

\ -

(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures; and r

l- (2) Surveys and bioassays, as appropriate, to evaluate actual intakes; and (3) Testing of respirators for operability immediately prior to each use; and

~

(4) Written procedures regarding selection, fitting, issuance, maintenance, and testing of respirators, including testing for operability immediately prior to each use; supervision and training of personnel; monitoring, including air sampling and bicassays; and recordkeeping; and

, .(5) Determination by a physician prior to initial fitting of respirators, and at least every 12 months thereafter, that the individual user is physically able to use the respiratory protection equipment, iv. The licensee shall issue a written policy statement on respirator usage covering:

(1) The use of process or other engineering controls, instead of respirators; and (2) The routine, nonroutine, and ernergency use of respirators; and (3) The length of periods of respirator use and relief from respirator use,

v. The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the' event of equipment malfunction, physical or psychological distress, procedural or communication failure. significant deterioration of operating conditions, or any other conditions that might require such relief.

vi.~ ' 'IThs'lidshseEshallissi'squipinint'Withih~liniitsti6ns"fddy%liihditi6ds of tise'ind

'shaliprojidelproperjvhual;353 ~llh$cc 355!!'-usi 5 hip 5.'5ht ^ $ hla the equipmca: manufac:urer's capra;cd limi:::ic= for typc and modc cf u;c and 2:!! provide proper r

veuah communication,W6thefiipedial'cpabilitici

!. (stichlaihdejdsteikiiip^r6tstioptien neededM l ,

c$c pccial capahilitic, such = adequa:c Ain prc:cc ica, when accded.

( -

i D22 O

3 m- y , ,e-, - , -,--- + ~ - ~ ,-n - ,- >,, . - , , ,-e-- -<<

b. When estimating exposure of individuals to airborne radioactive materials, the licensee may make allowance for respiratory protection equipment used to limit intakes pursuant to D.702, provided that the following conditions, in addition to those in D.703a., are satisfied:

i. The licensee selects respiratory protection equipment that provides a protection factor, sp:cified in Appendix A, greater than the multiple by which peak concentrat.cns of airborne radioactive materials in the working area are expected to exceul the values specified in Appendix B, Table 1, Column 3. However, if the

! selection of respiratory protection equipment with a protection factor greater than the peak concentratign is inconsistent with the goal specified in D.702 of keeping the total effective sose equivalent ALARA, the licensee may select respiratory protection equipmmt with a lower protection factor provided that such a selection would result in a iotal effective dose equivalent that is ALARA. The concentration of radioactive material in the air that is inhaled when respirators are worn may be initially estimated by dividing the average concentration in air, during each period of uninterrupted use, by the protection factor. If the exposure is later found to be greater than initially estimated, the corrected value shall be used; if the exposure is later found to be less than initially estimated, the corrected value may be used.

ii. The licensee shall obtain. authorization from the Agency before assigning respiratory protection factors in excess of those specified in Appendix A. The Agency may authorize a licensee to use higher protection factors on receipt of an application that: -

(1) Describes the situation for which a need exists for higher protection factors, and (2) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

c. In an emergency, the licensee shall use as emergency equipment only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration.

d. The licensee shall notify the Agency in writing at least 30 days before the date that respiratory protection equipment is first used pursuant to either D.703a. or b.

STORAGE AND CONTROL OF LICENSED OR REGISTERED SOURCES OF RADIATION l

Sec. D.801 Security of Stored Sources of Radiation.756ihEssof hidiitioifshall be'sedurbd aphihit

, , unauthorized jemoval?st"adce(fr6n[thii;plac{bf sibragei i$dic337 difIhtica 3EA!5; 3;cdcd l aga=t nau crized amcva! frca. $c ;-! ace of ::c=ge.

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J' Sec. D.802 Control of Sources of Radiation not in Storace.

a. The licensee shall control and maintain constant surveillance of licensed 0

1 D24 i

l l

l l

l iii. A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved; and l 1

iv. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas; and l

v. Actions that have been taken, or will be taken, to recover the source of radiation; and l vi. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

c. Subsequent to filing the written report required in D.1201(b), the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

1

d. The licensee or registrant shall prepare any report filed with the Agency pursuant to D.1201 I

i so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

Sec. D.1202 Notification of incidents. -

l

a. Immediate Notification. In addition to other requirements for notification, each licensee or I registrant shall immediately report by telephone each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

i. An individual to receive:

(1) A total effective dose equivalent of 0.25 Sv (25 rem) or more; or (2) An eye dose equivalent of 0.75 Sv (75 rem) or more; or, (3)? 1shal_lowTd6se equiidlent lofthsiskhFor;exifemitissl2; (3) A sha!!cv dose equivalent to the shin er-euremhies cr a total cri;an dose equ.valcat-of45 Gy (250 rad) or more; or ii. The telease of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> ;tisitidivid{ialicosidLhave received'an intake fiveitimes(thefAllWhc individual could have received an intake- five timeshe cecupational ALI This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

b. Twenty-Four Hour Notification. Each licensee or registrant shall, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovery of the event, report to the Agency in writing by telegram, mailgram or facsimile,

, ,, each event involving loss of control of a licensed or registered source of radiation possessed Supp.2 D36 l

l by the licensee or registrant that may have caused, or threatens to causs, any of the following conditions:

l.

i. An individual to receive, in a period of 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />s:

(1) A total effective dose equivalent exceeding 0.05 Sv (5 rem); or (2) An eye dose equivalent exceeding 0.15 Sv (15 rem); or (3)L l A* shallow dose' equivalent to the skin or ektremities exceeding 0.~ ( 3 )

Admikw-dese equ: valent tc4hc hkin or extremhies er a total crgan done equ: valent exceeding 0:5 Sv (50 rem); or ii. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

c. The licensee or registrant shall prepare each repon filed with the Agency pursuant to D.1202 so that names ofindividuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

d. The provisions of D.1202 do not apply to doses that result from planned special exposmes, provided such doses are within the limits for planned special exposures and are reported pursuant to D.206a and D.1204.

Sec. D.1203 Reoorts of Exoosures. Radiation Levels. and Concentrations of Radioactive Material Exceeding the I.imits,

a. Renonable Events. In additien to the notification required by D.1202. each licensee or registrant shall submit a written report to the Agency within 30 days afty learning of'any of the following occurrences:

i. Incidents for which notification is required by D.1202; or ii. Doses in excess of any of the following:

(1) The occupational dose limits for adults in D.201; or (2) The occupational dose limits for a minor in D.207; or (3) The limits for an embryo / fetus of a declared pregnant woman in D.208; or (4) The limits for an individual member of the public in D.301; or l

D37 Supp.2 I

l. '

l' (5) Any applicable limit in the license or registration; or l'. iii. Levels of radiation or concentrations of radioactive material in a restricted or unrestricted area in excess of the applicable limits set l l

l l

l 1

l l

l 1

1 1

l l

1 l

l l

l l l l

r Supp.2 D38 l

l

the licensee or registrant.

b. Each licensee or registrant shall retain a record of each misadministration for five years.

The record must contain the names of all individuals involved (including the prescribing physician, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the 1 misadministmtion, why it occurred, the effect on the patient, what improvements are j needed to prevent recurmnce, and the actions taken to prevent reoccurrence. 1 l

1

c. Aside from the notification requirement, nothing in this section affects any rights or J duties of licensees or registrants and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.

Sect Dil2101A~dditibnal Reo67tini Rschiisihesis foiRadi6adtiss' Malerials!

a6 f.ImihsdiatFiep6 GPich'liceh'ses'shall?h6tirp"theWgshdf'is sobit" ssp 6isible bul^nd later -

thin"4;hbddsftirihiiliscovsit.I;6f?

. ; . ; . . . , ; :/.: . . ~ .  ;;. . . ; ; ;; ; . anis. Vsnt thafpreveMs immidiate

_..a.,.-  : :- _ ;;-_ :. _ _ .; . :: . <.s n -~-n .

pt6tective -.actio.ns .

o I

. ... i couldTexceed neces.saryito. avo,id' 3..sexposur'es toiradiation:ior8 rad _ io(a;ctiv;e;imaterialsEth:at regniatdrylimit@prel$sse[ohiidens5hh$sterIalj tidiisddi1%cssdfregulst6ryflimits (eventsimay include fife.sKe.i. -- .

pissi6ss_Rioxic. wgas relsasesp~etcN..

-y . - . - . -

..., . u .,._- d .v N .p e::::. -

. v, >;,.s:,...,sc9 pfe "

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bn, . Twenty-four.,% ho,A . . ,NJ,en%,ur; reportEFishilic.-p,.,ensee;shsill ,, ,i,.,r,.notiff, the.y... Agencyp, ithin324lh,o,.

.~

urs;.a ... , . - fter the" discovery ~!of Anjnnfith . . . .

a ~~6.follo.w._ing"e.vehis inv6Nin, g. licensed--msis, ris,li l.:.,,. m f1iihnplAhhsdI6h6Unisili6,s.,"n"s9.;

- ,n 2 - e ....v. n v ~ n ,v.s. cn h,~ d.u i.e f liat?

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to t e contammated.w.:.,.wm.4.:by>. areat rs:or t eh,epu wor ke<vpue->... ., .y.blic.,ysw-tobs g .

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disBif Psh~. Di.and, i

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an ,to allo..,.. n.,....n. l nic ~'

a reason .._ , .,ww: isotopes  :

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s y;r - .- . . - - - 5. .egula, tion;or<h,e:ownense;condit' i plea ~ses .ceeex._en,dmg reg _ulatory;1imitstro prevent e.xposures c

.v radioactise{msterialsiejcssding j regplatodthnitsforjoimitigate l the i cqi.isequences;of an,accidenty lii , [The~edulgiihenfisisi edjtQbs bit antilsble shd'6;isrableyhsn it is dissbled j 4

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Supp.2 D42 i l

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I c. Preparat.ion an d sub~m,ission of:re_por. tsq,Re_p_. . , de b.,h,v.eensees ortgma m.? Lresponse to the.

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t requirements 6.f t.h..is_s.ec.t_ ion. mus.t_bs_: mads . .

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telephone;to th~e,Ag_e rep _ orts _.u! ( la l .- . L,ce. v, w .,i ..n. sees shill mid Lp . v w.v.w.se.ctids'by.~ I

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ency@To ve extent (t fed by.:,: iragraph( a-)... hd(b t

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ime ~of no>tificat.ion;;t he mfor~mation.r_ ,h~atLthelinforman.

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and. yesil_ bicl6,va.g.vw num bir;;

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and time;i 1 . . . , -.

i ni. ,Ttie exact l cat,on o iof th,e-ev.._. ,ent;3 in jTh511s6tbpssTq$dj7

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2. fWritten reportHEshh,lic,juy,y,. <,,,wgg,gg.enseeyho, .,, ww.v,3s a;repor j make.sp,,v ggg.,,p.., u, equire b.y=.wyn .v g g ,Nd.> b. .AyN M.V.s .y,p.aragrapliy(s),.'o. r s.

(b)lof this senti 6. it shall"ssbmiFMirittsii

~ m .~ follosidh,. sp,6itisithin~230?daysi.6f'the - o +.

md. ialg. epprtO.

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, Written:r,eports?preparedjpu.

nnrsua_nt;toiothe~rfregulations

. mayi ub- e..

submittsd,3,.. to; fulfill;tlu,ite,quirementfitstheimpo. s

,~=c ~ n rtsicontamrallioff 3~

the n=ecessary

.m. fo rmat3on an . d the upp.s.ropnate disk +ibutionis s madsdThese: re: ports must be s.ent t.d. the". A.. gen _cpMThe. rep.,otti,m. sst,in.cl. udn...he!_fol..l.o..

w_ _ n win.gi

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D42-1 Supp.2

, - _ _ _- . _ _ _ _.4 ilT.."%T.~hsi.

.s M. id,diiiiWR,,,_th,Ei__.V.

ssFt l 8

l f,

lii(. -l(Thelis6(6 pes"45sititiss,*'id'd'6hithicil(ssdlph sidsl[fohh~of;the licensed I material:inv.olve,d>h  !

iV'. tDate add"tinis'6fjjihij}

t l Corrective actiositiksn b[ planned.snd th'e7essitsjf any;eyaluations or assessments;;and '

\

, vi: " The' e'xieht'.'ofTexpossre^ :;of ~ individual [t6l radiatidd br~to radioactive I materials .withon't :iden.tificationLof. individuals by name.

i ADDITIONAL REQUIREMENTS l Sec. D.1301 Vacatine Premises, 4

(See also C.32,1"Expirati6n#andiTe'rmisstion"6f Lidanses snd Dec6ismissioning'of. Sites and

~"

Separate Buildings lorfOutdoor%reas")[

"Expim:ica and Te=inatica of Licen:c ")

Each specific licensee shall, no less than 30 days before vacating or relinquishing possession or i  ;

control of premises or other authorized use location which may have been contaminated with l radioactive material'as a result of his activities, notify in writing of intent to vacate and submit a written decontamination survey to the Agency, When deemed necessary by the Agency, the licensee shall decontaminate the premises in such a manner as the Agency may specify.

1 4

i 1

A

}.

Supp.2 D42-2 f

4

a .

i

[- shall immediately withdraw the source from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with these regulations. A report describing the equipment involved, the test results, and the corrective action taken shdi be filed with~the Agency within 5 days of receiving the test results.

(e) Exemptions. The following sources are exempted from the periodic leak test requirements of 4 W.105(a) through (d):

l s (1) hydrogen-3 sources; (2) sources of radioactive material with a half-life of 30 days or less; s '

(3) sealed sources of radioactive material in gaseous form;

1 (4) sources of beta- or gamma-emitting radioactive material with an activity of 100 microcuries

, (3.7 h18q) or less; and (5) sources of alpha-emitting radioactive material with aa activity of 10 microcuries (0.370 h18q) i or less.

i l

Sec. W.106 Ouarterly inventory. Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation. Records of inventories shall be maintained for 2 years from the j date of the inventory for inspection by the Agency and shall include the quantities and kinds of sources of radiation, the location where sources of radiation are assigned, the date of the inventory, and the name of the individual conducting the inventory.

Sec. W.107 Utilization Records. Each licensee or registrant shall maintain current records, which shall be kept available for inspection by the Agency for 2 years from the date of the recorded event, showing the following information for each source of radiation:

(a) make, model number, and a serial number or a description of each source of radiation used; (b) the identity of the well-logging supervisor or field unit to whom assigned; (c) locations where used and dates of use; and (d) in the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.

Sec. W.108!Use,} Design, Performance, and Certification Criteria for Sealed Sources Used in Downhole Operations.

(a) Each sealed source, except those containing radioactive material in gaseous form, used in downhole operations and manufactured after September 21,1987 shall be certified by the manufacturer, or other testing organization acceptable to the Agency, to meet the following minimum criteria:

l[C e

e-- ..- . - -..__ - - -. -.- - ..- -- -- - - - - - - - ~

n . . .

l i l

(1) be of doubly encapsulated construction; (2) contain radioactive material whose chemical and physical forms are as insoluble and non- .

j dispersible as practical; and

(3) has been individually pressure tested to at least 24,656 pounds per square inch absolute (170 2

i MN/m ) without failure.

1 (b) . For sealed sources, except those containing radioactive material in gaseous form, acquired after September 21,1987 in the absence of a certificate from a transferor certifying that an individual sealed

! source ' meets the requirements of W.108(a), the sealed source shall not be put into use until such determinations and testing have been performed.

(c) Each sealed source, except those containing radioactive material in gaseous form, used in downhole j operations after September 21,1988 shall be certified by the manufacturer, or other testing organization i acceptable to the Agency, as meeting the sealed source performance requirements for oil well-logging as

) contained in the American National Standard N43.6, " Classification of Sealed Radioactive Sources," ,

j (formerly N542, ANSI /NBS 126) in effect on September 21,1986. '

j (d) Certification documents shall be maintained for inspection by the Agency for a period of 2 years after l source disposal. If the source is abandoned downhole, the certification documents shall be maintained

until the Agency authorizes disposition.

(e)? T IThe lic4nsee'may us41i s6aled sobrhe iri s well fith6ut a surfacicasing for protecting fresh water

~

j aquifersionlyfif.the licenseefollowsta~pr6dedufifdrieducing the'pfobshilitfofithe?s6urce becoming j lodgnd;in the3vEinThelprodsdure musibe approvni byMNucle~ai RdghlatodCommbsion. pursuant is~10 CAR (Sed.}39M(c);or^ bplthe' fgency.

Sec. W.109 Labeling.

(a) Each source, source holder, or logging tool containing radioactive material shall bear a durable, legible, and clearly visible marking or label, which has, as a minimum, the standard radiation caution symbol, without the conventional color requirement, and the following wording:

DANGERjf RADIOACTIVE This labeling shall be on the smallest component transported as a separate piece of equipment.

(b) Each transport container shall have permanently attached to it a durable, legible, and clearly visible label which has, as a minimum, the standard radiation caution symbol and the following wording:

DANGER' RADIOACTIVE NOTIFY CIVIL AUTHORITIES [OR NAME OF COMPANY]

W5 Supp.2

~ m+s e

l -

y, - - -

Sec. W.110 Inspection and Maintenance, i

9 l (a) Each licensee or registrant shall conduct, at intervals not to exceed 6 months, a program of inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools to assure proper labeling and physical condition. Records of inspection and maintenance shall be maintained for a period of 2 years for inspection by th Agency.

1 (b) If any inspection conducted pursux 1 to W.110(a) reveals damage to labeling or components critical l to radiation safety, the device shall be removed frorn service until repairs have been made.

(c) If a sealed source is stuck in the source holder, the licensee shall not perform any operation, such as drilling, cutting, or chiseling, on the source holder unless the licensee is specifically approved by the Agency.

(d) The repair, opening, or modification of any sealed source shall be performed only by persons specifically authorized to do so by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

Requirements for Personnel Safety Sec. W.201 Training Reauirements.

(a) No licensee or registrant shall permit any individual to act as a logging supervisor as defined in this part until such individual has:

(1) received, in a course recognized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, instruction in the subjects outlined in Appendix A of this part and demonstrated an understanding thereof; (2) read and received instruction in the regulations contained in this part and the applicable sections of Parts A, D, and J of these regulations or their equivalent, conditions of appropriate license or certificate of registration, and the licensee's or registrant's operating and emergency procedures, and demonstrated an understanding thereof; and (3) demonstrated competence to use sources of radiation, related handling tools, and radiation survey instruments which will be used on the job.

(b) No licensee or registrant shall permit any individual to assist in the handling of sources of radiation until such individual has:

(1) read or received instruction in the licensee's or registrant's operating and emergency procedures and demonstrated an understanding thereof; and (2) demonstrated competence to use, under the personal supervision of the logging supervis~or, the sources of radiation, related handling tools, and radiation survey instruments which will j be used on the job.

Supp.2 W6 l

l

, (c) The licensee or registrant shall maintain employee training records for inspection by the Agency for 2 years following termination of the individual's employment. ,

Sec. W.202 'Oneratine and Emercency Procedureji. The licensee's or registrant's operating and emergency procedures shall include instructions in at least the following:  ;

(a) handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation doses in excess of the standards established in Part D of these regulations; (b) methods and occasions for conducting radiation surveys; (c) methods and occasions for locking and securing sources of radiation; (d) personnel monitoring and the use of personnel monitoring equipment; (e) transportation to temporaryjobsites and field stations, including the packaging and placing of sources of radiation in vehicles, placarding of vehicles, and securing. sources of radiation during transportation; (f) minimizing exposure of individuals in the event of an accident; (g) maintenance of records; (h) use, inspection and maintenance of source holders, logging tools, source handling tools, storage l containers, transport containers, and injection tools; (i) procedure to be followed in the event a sealed source is lodged downhole; (j) procedures to be used for picking up, receiving, and opening packages containing radioactive material; (k) for the use of tracers, decontamination of the environment, equipment, and personnel; (1) maintenance of records generated by logging personnel at temporary jobsites; (m) notifying proper persons in the event of an accident; and (n) actions to be taken if a tealed source is ruptured, including actions to prevent the spread of contamination and minimize inhalation and ingestion of radioactive material and actions to obtain suitable radiation survey instruments as required by W.104.

Sec. W.203 Personnel Monitorine.

(a) No licensee or registrant shall permit any individual to act as a logging supervisor or to assist in the handling of sources of radiation unless each such individual wears either a film badge or a thermolumi-nescent dosimeter (TLD). Each film badge or TLD shall be assigned to and worn by only one individual.

Film badges must be replaced at least monthly and TLDs replaced at least quarterly. After replacement, each film badge or TLD must be promptly processed.

(b) Personnel monitoring records shall be maintained for inspection until the Agency authorizes W7 Supp.2

_ . __ _ . . __ _ _ __ - _._ ___ . _ . . . . .m _. _ _ _ _

4 l

disposition.

J l

Precautionary Procedures in Logging an'd Subsurface Tracer Studies l Sec. W.301 Security. During each logging or tracer application, the logging supervisor or other designated employee shall maintain direct surveillance of the operation to protect against unauthorized l

or uunecessary entry into a restricted area, as defined in Part A of these regulations.

Sec. W.302 Handline Tools. The licensee shall provide and require the use of tools that will assure remote handling of sealed sources other than low-activity calibration sources.

, Sec. W.303 Subsurface Tracer Studies, i

(a) Protective gloves and other appropriate protective clothing and equipment shall be used by all

' personnel helling radioactive tracer material. Precautions shall be taken to avoid ingestion or inhalation of radioactive material, j (b) No licensee shall cause the injection of radioactive material into potable aquifers without prior written authorization from the Agency.

\

Sec. W.304 Particle Accelerators. No licensee or registrant shall permit above-ground testing of particle

accelerators, designed for use in well- logging, which results in the production of radiation, except in j areas or facilities so controlled or shielded that the requirements of D.201 and D 301 of these regulations, j as applicable, are met.

Sec. W.305? Uranium Sinker BarsRThs licensee fnayLdsEa uranism'iinket bar iniwell logging only if .

it is legibly impressed fwith the words1CAUTIONRRADIOACTIVE DEPLETED; URANIUM *l and

" NOTIFY CIVIL %UTHORITIESj(o.r.;C.OMPANWN.AME)IFf00NDy l

Radiation Surveys and Records Sec. W.401 Radiation Survevs.

(a) Radiation surveys or calculations shall be made and recorded for each area where radioactive materials are used and stored. j (b) Radiation surveys shall be made and recorded for the radiation levels in occupied positions and on the exterior of each vehicle used to transport radioactive material. Such surveys shall include each source of radiation or combination of sources to be transported in the vehicle.

(c) If the sealed source assembly is removed from the logging tool before departing the jobsite, the logging tool detector shall be energized, or a survey meter used, to assure that the logging tool is free of contamination.

Supp.2 W8