October 25, 2004

Mr. John L. Ferruolo

Supervising Radiological Health Specialist

Office of Occupational and Radiological Health

Department of Health

3 Capitol Hill

Providence RI. 02908-5097

Dear Mr. Ferruolo:

We have reviewed the final R23-1.3-RAD, “Rhode Island Rules and Regulations for the Control

of Radiation”, received by this office on September 7, 2004. Our review and comments are in

response to the State’s request for NRC evaluation of the changes to Rhode Island’s radiation

control rules that incorporated the amendments identified on the enclosed State Regulation

Status Data Sheet (SRS). The submitted final regulations were reviewed by comparison to the

equivalent NRC regulations in 10 CFR Parts 19, 20, 30, 32, 34, 35, 36, 39, 61, 71, 150 and the

requirements of the eleven amendments identified on the SRS Data Sheet. We discussed our

review of the regulations with you, during an October 25, 2004 email transmittal.

As a result of our review, we have no new comments regarding these regulations and have

found that all but five of the comments from our July 9, 2004 letter have been addressed and

are now closed. However, the five comments that remain open from that letter are enclosed in

the attached chart. We note that for comments number one, three, and four, the office

committed, in our discussion, to addressing these in a future rulemaking, which is still an

acceptable course of action. In regards to comment number two, from the July 9, 2004 letter,

we did not find the correction to the multiplier factor, per your committment. If this omission

was an oversight, please include this change in your future rulemaking as well. In regards to

comment number five, you committed to developing license conditions to apply to your current

licensees. We did not find your rule text had been changed to meet this requirement, and if

you have developed license conditions to address this, we request you submit the license

conditions to the NRC for review. 

When you have completed your future rulemaking, please provide an amended final version of

your rules showing the location of any changes made by the State, in response to our

comments. If there are any comments which Rhode Island believes are in error, the State

should identify the sections of their regulations that meet the designated compatibility category

for the areas in question and submit them to the NRC for review. Please note that we have

limited our review to regulations required for compatibility and/or health and safety. However,

we have determined that if these regulations are adopted, incorporating our comments and

without significant change, they would meet the compatibility and health and safety categories

established in the Office of State and Tribal Programs (STP) Procedure SA-200.

The SRS Data Sheet summarizes our knowledge of the status of other Rhode Island

regulations, as indicated. Please let us know if you note any inaccuracies, or have any

comments on the information contained in the SRS Data Sheet. This letter, including the SRS

Data Sheet, is posted on the STP website: http://www.hrsd.ornl.gov/nrc/rulemaking.htm.

Mr. John L. Ferruolo -2- October 25, 2004
If you have any questions regarding the comments, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact me, or John Zabko

of my staff, at (301)415-2308 or JGZ@NRC.GOV. 

Sincerely,

\RA BY K.N. SCHNEIDER FOR\

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures:

As stated
Mr. John L. Ferruolo -2- October 25, 2004

If you have any questions regarding the comments, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact me, or John Zabko

of my staff, at (301)415-2308 or JGZ@NRC.GOV. 

Sincerely,

\RA BY K.N. SCHNEIDER FOR\

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures:

As stated

Distribution:

DIR RF [ 4-276] Rhode Island DCD PDR (YES T) DWhite RSAO

DSollenberger, ASPO Response to Incoming Document: ML042520322 Rhode Island File

DOCUMENT NAME: E:\Filenet\ML043010048.wpd

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with

attachment/enclosure "N" = No copy

OFFICE STP STP OGC STP:DD

NAME OSiurano JZabko Streby KNS for Jpiccone

DATE 10/13/04* 10/13/04* 10/21/04* 10/25/04*

ML043010048 OFFICIAL RECORD COPY 
COMMENTS ON RHODE ISLAND PROPOSED REGULATIONS

Number State

Regulation

 

NRC

Section

RATS 

ID 

Category Subject and Comments

1 A.0 71.4 1996-1 B a) The State’s proposed regulation does not

include the following definition: “Certificate

Holder”

b) In addition, the State’s proposed

regulations includes the phrase “or other

form” in their proposed definition for Normal

Form - Radioactive Material

The State needs to include this definition and

remove the phrase “or other form” from their

proposed definition for Normal Form

Radioactive Material to meet compatibility.

The previous comment on this section

concerning the addition of the following

definitions is withdrawn: Definition of A1 and

A2, Conveyance, Package

The State makes reference to 49 CFR 173,

Subpart I, in Section C.7.4(a)(1)(i), which

includes these definitions.

2 C.7.10 71.18 1996-1 B General License: Fissile Material, limited

quantity per package

The State’s proposed regulations did not

include paragraphs d & e for fissile materials. 

Also the transport index calculation appears

to be in error. State defines a 15 gram

minimum requirement for fissile material

which is not discussed in this section of NRC

regulations, and the multiplier for plutonium

beryllium sources is noted as 0.026. NRC

regulations state 0.025.

The State needs to amend their regulations 

to incorporate the essential objectives of the

text of 71.18.
3 C.7.7 71.13 1996-1 B Previously Approved Package

The State’s proposed regulations at

C.7.7.(b)(2) contains the phrase, “approval

except approved under special arrangement

in accordance with,” instead of “approval as

defined in.”

The State needs to revise its regulations and

replace the phrase, “approval except

approved under special arrangement in

accordance with,” with the phrase “approval

as defined in.”

4 C.7.19 71.101

71.103

71.105

1996-1 C Quality Assurance Requirements; Quality

Assurance Organization; Quality

Assurance Program

The State’s proposed regulations regarding

Quality Assurance did not include the

language contained in 71.101(g) which

specifies quality assurance requirements and

organization, including specific requirements

for radiography containers.

State needs to revise their regulations to

include requirements for radiography

containers as discussed in 71.101(g).

5 N/A 40.36

H&S--

paragrap

hs 

(a), (b),

(d), and

(f).

1997-6

2003-1

H&S Financial assurance and recordkeeping

for decommissioning (source material)

The State’s proposed regulations define

financial assurance requirements for

radioactive materials, using §30.35 model

(Appendix B to Part 30 values times a

multiplier). This approach does not work for

source material (uranium and thorium). The

10 mCi and 100 mCi thresholds in §40.36

are not met with the §30.35 methodology. 

As written in §40.36 and §40.42, the specific

threshold for source material needs to be

explicitly stated in the State regulation or

other legally binding requirement, to

establish a compatible financial assurance

system for source materials.

The State rule in C.5.16 is not equivalent to

§40.36. As such, the State needs to draft

a rule equivalent to §40.36 to meet

compatibility.

Editorial Suggestions

1. Section C.5.8 (f)(4)(vi) - reference to paragraph (g) is incorrect. The correct reference

 should be to paragraph (h).

2. Section C.5.8 (d) - C.5.16 is not equivalent to §40.36. Reference to C.5.16 should be

 revised.
STATE REGULATION STATUS

State: Rhode Island [11 amendments reviewed are identified by a i Tracking Ticket Number: 4-276 at the beginning of each equivalent NRC regulation.] Date: 10/25/2004

NRC Chronology Identification FR Notice

(Date Due for State Implementation))

RATS ID Proposed (P) /

Final (F)1 Rule / 

ML #4

Safety Requirements for Radiographic Equipment-Part 34 55 FR 843; (1/10/94) 1991-1ASNT Certification of Radiographers-Part 34 56 FR 11504; (none) 1991-2 Standards for Protection Against Radiation-Part 20 56 FR 23360; 56 FR 61352;

57 FR 38588; 57 FR 57877;58 FR 67657; 59 FR 41641;60 FR 20183; (1/1/94)

1991-3 F-N 

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 F-N Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 F-N Eliminating the Recordkeeping Requirements for Departures from Manufacturer'sInstructions-Parts 30,35

57 FR 45566; (none) 1992-2 

Decommissioning Recordkeeping and License Termination: DocumentationAdditions [Restricted areas and spill sites]-Parts 30, 40 

58 FR 39628; (10/25/96) 1993-1 F-N 

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 Definition of Land Disposal and Waste Site QA Program-Part 61 58 FR 33886; (7/22/96) 1993-3 Self-Guarantee as an Additional Financial Mechanism-Parts 30, 40, 70 58 FR 68726; 59 FR 1618

(none)

1994-1 F-N 

Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPAStandards-Part 40

59 FR 28220; (7/1/97) 1994-2 

Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3 F-N Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material forMedical Use-Parts 30, 32, 35

59 FR 61767; 59 FR 6524360 FR 322; (1/1/98)

1995-1 F-N 

Frequency of Medical Examinations for Use of Respiratory Protection EquipmentPart 20 60 FR 7900; (3/13/98) 1995-2 F-N Low-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983

(3/1/98)

1995-3 F-N 

Performance Requirements for Radiography Equipment-Part 34 60 FR 28323; (6/30/98) 1995-4 F-N Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 F-Y Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 F-N 
NRC Chronology Identification FR Notice

(Date Due for State Implementation))

RATS ID Proposed (P) /

Final (F)1 Rule / 

ML #4

Medical Administration of Radiation and Radioactive Materials-Parts 20, 35 60 FR 48623; (10/20/98) 1995-7 F-N i10 CFR Part 71: Compatibility with the International Atomic Energy Agency-Part

71

60 FR 50248; 61 FR 28723(4/1/99)

1996-1 F

ML042520322

One Time Extension of Certain Byproduct, Source and Special Nuclear MaterialsLicenses-Parts 30, 40, 70

61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: Recordkeeping Requirements-Parts20, 30, 40, 61, 70

61 FR 24669; (6/17/99) 1996-3 F-N 

iResolution of Dual Regulation of Airborne Effluents of Radioactive Materials;

Clean Air Act-Part 20

61 FR 65120; (1/9/00) 1997-1 F

ML042520322

Recognition of Agreement State Licenses in Areas Under Exclusive FederalJurisdiction Within an Agreement State-Part 150

62 FR 1662; (2/27/00) 1997-2

Criteria for the Release of Individuals Administered Radioactive MaterialParts 20, 35 62 FR 4120; (5/29/00) 1997-3 F-N Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 

Licenses for Industrial Radiography and Radiation Safety Requirements forIndustrial Radiography Operations-Parts 30, 34, 71, 150

62 FR 28948; (6/27/00) 1997-5 F-N 

iRadiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39058; (8/20/00) 1997-6 F-Y

ML042520322

Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14Urea-Part 30 

62 FR 63634; (1/02/01) 1997-7 F-N 

iDeliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 F

ML042520322

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-IssuingLicensees- Parts 30, 40, 70

63 FR 29535; (none) 1998-2 ML042520322 

License Term for Medical Use Licenses-Part 35 63 FR 31604; (none) 1998-3 Licenses for Industrial Radiography and Radiation Safety Requirements forIndustrial Radiographic Operations-Part 34

63 FR 37059; (7/9/01) 1998-4 F-N 

Minor Corrections, Clarifying Changes, and a Minor Policy Change-Parts 20, 35, 36 63 FR 39477; 63 FR 45393

(10/26/01)

1998-5 F-N 

Transfer for Disposal and Manifests: Minor Technical Conforming AmendmentPart 20 63 FR 50127; (11/20/01) 1998-6 F-N 
NRC Chronology Identification FR Notice

(Date Due for State Implementation))

RATS ID Proposed (P) /

Final (F)1 Rule / 

ML #4

Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1 Requirements for Those Who Possess Certain Industrial Devices ContainingByproduct Material to Provide Requested Information-Part 31

64 FR 42269; (none) 1999-2 

iRespiratory Protection and Controls to Restrict Internal Exposure-Part 20 64 FR 54543; 64 FR 55524

(2/2/03)

1999-3 F

ML04520322

iEnergy Compensation Sources for Well Logging and Other Regulatory

Clarifications-Part 39

65 FR 20337; (5/17/03) 2000-1 F

ML04520322

iNew Dosimetry Technology-Parts 34, 36, 39 65 FR 63749; (1/8/04) 2000-2 F

ML04250322

i Requirements for Certain Generally Licensed Industrial Devices Containing 

Byproduct Material - Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 F

ML04520322

iRevision of the Skin Dose Limit-Part 20 67 FR 1629; (4/5/05) 2002-1 F

ML04520322

iMedical Use of Byproduct Material-Parts 20, 32, 35 67 FR 20249; (10/25/05) 2002-2 F

ML04520322

iFinancial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1 F

ML04520322

Compatibility With IAEA Transportation Safety Standards and OtherTransportation Safety Amendments - Part 71

2004-1

1. Or other generic Legally Binding Requirements.

2. (Y/N) Y means “Yes,” there are comments in the review letter that the State needs to address. 

N means “No,” there are no comments in the review letter.

3. Not required means these regulations are not required for purposes of compatibility.4. A State need not adopt a specific regulation if the State has no licensees that would be subject to that regulation. See: “Final Polic

Adequacy and Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, 1995.

5. ADAMS ML Number