May 4, 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 proposed changes to the Rhode Island regulations, R23-1.3-RAD,

“Rhode Island Rules and Regulations for the Control of Radiation”, received by our office on

March 16, 2004 and supplemented by e-mail on April 5, 2004. Our review and comments are in

response to the State’s request for Nuclear Regulatory Commission (NRC) evaluation of the

changes to Rhode Island’s radiation control rules that incorporated the amendments identified

on the State Regulation Status Data Sheet (SRS). These regulations were reviewed by

comparison to the equivalent NRC rules in 10 CFR Parts 20, 30, 32, 35, 39, 40, 70, 71 and 150

and the requirements of the eleven amendments identified in the enclosed SRS. We informed

you of the results of our initial review in a conversation in which we discussed our review of the

regulations with Mr. William Dundulis, of your staff, on March 31, 2004.

As a result of our review, we have ten comments. Under our current procedure, a finding that a

State regulation meets the compatibility and health and safety categories of the equivalent NRC

regulation may only be made based on a review of the final State regulation. Please provide a

final amended version of your rules showing the location of any changes made in response to

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

should identify the section of their regulations that meet the designated compatibility category. 

Please note that we have limited our review to regulations required for compatibility and/or

health and safety, but 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 SA200, “Compatibility Categories and Health and Safety Identification for NRC Regulations and

Other Program Elements.” (STP-02-075)

In STP-02-075, dated October 25, 2002, STP notified the Agreement States of the proposed

revisions and changes to SA-200 regarding compatibility determinations, including changes to

Part 71. Several compatibility designations were changed from “D” to “C” because the

identified activities for Type B packages are needed in order to avoid a nationwide regulatory

gap. These changes are not reflected in the 1999 Suggested State Regulations for the Control

of Radiation (SSRCR) revision for Transportation regulations. We will be coordinating with the

Conference of Radiation Control Program Directors to clarify and revise the SSRCR.

We have also identified a number of issues related to training and experience requirements of

persons conducting activities under 10 CFR Part 35, “Medical Use of Byproduct Material.” We

understand that these items will be resolved at a later date when Rhode Island revises that part 
Mr. John L. Ferruolo -2- May 4, 2004

of the regulations containing these requirements. We have included them in a separate chart

for your convenience, and no action on these items is required at this time.

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.

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 

Ms Patricia Eng of my staff at (301) 415-7206 or PLE@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- May 4, 2004

of the regulations containing these requirements. We have included them in a separate chart

for your convenience, and no action on these items is required at this time.

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.

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 

Ms Patricia Eng of my staff at (301) 415-7206 or PLE@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 [4-61]

Rhode Island DCD PDR (YES_) DSollenberger, ASPO

DWhite RSAO Response to Incoming Document: ML040760420

Rhode Island File

DOCUMENT NAME: C:\ORPCheckout\FileNET\ML041340017.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 PLEng JZabko STreby KNSchneider for

JPiccone

DATE 04/15/04* 04/15/04* 05/03/04* 05/04/04*

ML041340017 OFFICIAL RECORD COPY

COMMENTS ON PROPOSED RHODE ISLAND REGULATIONS
AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES

Number State

Regulation

 

NRC

Sectio

n

RATS 

 ID 

 

Category Subject and Comments

1 A.0 71.4 1996-1 B The State’s proposed regulations do not

include the following definitions:

Definition of A1 and A2

Certificate Holder

Conveyance

Package

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 the definitions of

Definition of A1 and A2, Certificate Holder,

Conveyance and package; and remove the

phrase “or other form” from their proposed

definition for Normal form radioactive material

to meet compatibility.

2 C.8.30 35.200 2002-2 H&S Use of Unsealed Byproduct Materials for

Imaging and Localization Studies for which

a Written Directive is not Required.

In paragraph (a) the State’s proposed

regulations use the phrase “involving

measurements of the uptake, dilution or

excretion studies,” instead of “for imaging and

localization studies for which a written directive

is not required.”

The State needs to replace the phrase

“involving measurements of the uptake, dilution

or excretion studies,” with the phrase “for

imaging and localization studies for which a

written directive is not required.”

3 C.7.6 71.12 1996-1 B General License: NRC-approved package.

The State’s proposed regulations did not

include this requirement.

The State needs to revise their regulations to

include the requirement for an approved

Quality Assurance Program.
4 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.

5 C.7.7 71.13 1996-1 B 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.”

6 C.7.14 71.87 1996-1 B Routine Determinations

The State’s proposed regulations did not

include the words “with its contents”

The State needs to add the words, “with its

contents” as noted in 71.87, thereby

incorporating the essential objectives of the

text of 71.87
7 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(a), (b), (c) and (g) which

specifies quality assurance requirements and

organization, including specific requirements

for radiography containers.

State needs to revise their regulations to

include design, purchase, fabrication, handling,

storing, cleaning, inspection ,testing,

operations, maintenance, repair and

modification activities under a QA program. 

State should also include a discussion of QA

organizations and programs similar to 71.103

in order to incorporate the essential objectives

of the text of 71.101; and 71.103, including

requirements for radiography containers as

discussed in 71.101(g).

8 N/A 40.36

H&S--

paragra

phs 

(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 the 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 achieved met with the 30.35 methodology. 

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 unsealed source material. 
9 C.5.8 40.42 1997-6 H&S Expiration and termination of licenses and

decommissioning of sites and separate

buildings or outdoor areas

The State’s proposed regulations did not

explicitly include the regulatory requirements

defined in 40.42 paragraphs (c), (d), (e), (f),

(g), (h), (i), (j), & (k)(1), (2), (3) regarding

source material.

The State needs to revise its regulations to

include the regulatory requirements defined in

40.42 paragraphs (c), (d), (e), (f), (g), (h), (i),

(j), & (k)(1), (2), (3) regarding source material.

10 A.2.3 20.120

1

2002-1 A Occupational dose limits for adults

The State’s proposed regulations added the

phrase “shallow dose equivalent” to the first

sentence in paragraph A.2.3.c, and to the

second sentence after the word, “assigned”

The State also omitted the sentence, “The

deep-dose equivalent, lens-dose equivalent,

and shallow dose equivalent may be assessed

from surveys or other radiation measurements

for the purpose of demonstrating compliance

with the occupational dose limits, if the

individual monitoring device was not in the

region of highest potential exposure, or the

results of individual monitoring are

unavailable.”

The State needs to remove the two references

to shallow-dose equivalent in paragraph

A.2.3.c, and add the sentence noted above in

order to incorporate the essential objectives of

the text of 20.1201
 COMMENTS ON PROPOSED RHODE ISLAND REGULATIONS AGAINST COMPATIBILITY

AND HEALTH AND SAFETY CATEGORIES FOR TRAINING REQUIREMENTS FOR MEDICAL

LICENSEES

State

Regulation

 

NRC

Regulation

RATS 

 ID 

 

Category Subject and Comments

C.8.62 35.50 2002-2 B Training for Radiation Safety

Officer

The State has retained part of the

previous Part 35 training

requirements; however, in its letter

transmitting this amendment, the

State noted that it will amend

training requirements for physician

authorized users upon completion

of NRC’s current 10 CFR 35

rulemaking regarding training

requirements for physician

authorized users.

The State should revise this

requirement when the NRC

rulemaking for Part 35 on training is

completed.

C.8.71 35.51 2002-2 B Training for an Authorized

Medical Physicist

The State has retained part of the

previous Part 35 training

requirements; however, in its letter

transmitting this amendment, the

State noted that it will amend

training requirements for an

authorized medical physicist on 

completion of NRC’s current 10

CFR 35 rulemaking regarding

pertinent training requirements.

The State should revise this

requirement when the NRC

rulemaking for Part 35 on training is

completed.
C.8.76 35.55 2002-2 B Training for an authorized

nuclear pharmacist

The State has retained part of the

previous Part 35 training

requirements; however, in its letter

transmitting this amendment, the

State noted that it will amend

training requirements for an

authorized nuclear pharmacist upon

completion of NRC’s current 10

CFR 35 rulemaking regarding

pertinent training requirements.

The State should revise this

requirement when the NRC

rulemaking for Part 35 on training is

completed.

C.8.63

C.8.72

C.8.73

C.8.77

35.57 2002-2 B Training for experienced

Radiation Safety Officer,

teletherapy or medical physicist,

authorized user, and nuclear

pharmacist

The State has retained part of the

previous Part 35 training

requirements; however, in its letter

transmitting this amendment noted

that it will amend training

requirements for experienced

Radiation Safety Officer,

teletherapy or medical physicist,

authorized user, and nuclear

pharmacist upon completion of

NRC’s current 10 CFR 35

rulemaking regarding pertinent

training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.
C.8.64 35.190 2002-2 B Training for uptake, dilution and

excretion studies

The State has retained part of the

previous Part 35 training

requirements; however, its letter

transmitting this amendment noted

that it will amend training

requirements for uptake, dilution

and excretion studies upon

completion of NRC’s current 10

CFR 35 rulemaking regarding

pertinent training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.

C.8.65 35.290 2002-2 B Training for imaging and

localization studies

The State has retained part of the

previous Part 35 training

requirements; however, its letter

transmitting this amendment noted

that it will amend training

requirements for imaging and

localization studies upon completion

of NRC’s current 10 CFR 35

rulemaking regarding pertinent

training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.
C.8.66 35.390 2002-2 B Training for use of unsealed

byproduct material for which a

written directive is required

The State has retained part of the

previous Part 35 training

requirements; however, its letter

transmitting this amendment noted

that it will amend training

requirements for use of unsealed

byproduct material for which a

written directive is required upon

completion of NRC’s current 10

CFR 35 rulemaking regarding

pertinent training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.

N/A 35.392 2002-2 B Training for the oral

administration of sodium iodide

I-131 requiring a written directive

in quantities less than or equal to

1.22 Gigabecquerels (33

microcuries)

The State does not have

regulations for the the oral

administration of sodium iodide I131 requiring a written directive in

quantities less than or equal to 1.22

Gigabecquerels (33 microcuries). 

In its letter transmitting this

amendment, the State noted that it

will amend training requirements

upon completion of NRC’s current

10 CFR 35 rulemaking regarding

pertinent training requirements.

The State should include

regulations addressing this NRC

requirement when the NRC

rulemaking for Part 35 on training is

completed.
N/A 35.394 2002-2 B Training for the oral

administration of sodium iodide

I-131 requiring a written directive

in quantities greater than 1.22

Gigabecquerels (33 microcuries)

The State does not have

regulations for the the oral

administration of sodium iodide I131 requiring a written directive in

quantities greater than 1.22

Gigabecquerels (33 microcuries). 

In its letter transmitting this

amendment, the State noted that it

will amend training requirements

upon completion of NRC’s current

10 CFR 35 rulemaking regarding

pertinent training requirements.

The State should include

regulations addressing this NRC

requirement when the NRC

rulemaking for Part 35 on training is

completed.

C.8.67 35.490 2002-2 B Training for use of manual

brachytherapy sources

The State has retained part of the

previous Part 35 training

requirements; however, its letter

transmitting this amendment noted

that it will amend training

requirements for use of manual

brachytherapy sources upon

completion of NRC’s current 10

CFR 35 rulemaking regarding

pertinent training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.
C.8.68 35.491 2002-2 B Training for ophthalmic use of

strontium-90

The State has retained part of the

previous Part 35 training

requirements; however, its letter

transmitting this amendment noted

that it will amend training

requirements for ophthalmic use of

strontium-90 upon completion of

NRC’s current 10 CFR 35

rulemaking regarding pertinent

training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.

C.8.69 35.590 2002-2 B Training for use of sealed

sources for diagnosis

The State has retained part of the

previous Part 35 training

requirements; however, its letter

transmitting this amendment noted

that it will amend training

requirements for use of sealed

sources for diagnosis upon

completion of NRC’s current 10

CFR 35 rulemaking regarding

pertinent training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.
C.8.70 35.690 2002-2 B Training for use of remote

afterloader units, teletherapy

units, and gamma stereotactic

radiosurgery units

The State has retained part of the

previous Part 35 training

requirements; however, its letter

transmitting this amendment noted

that it will amend training

requirements for use of remote

afterloader units, teletherapy units,

and gamma stereotactic

radiosurgery units upon completion

of NRC’s current 10 CFR 35

rulemaking regarding pertinent

training requirements.

The State should revise these

requirements when the NRC

rulemaking for Part 35 on training is

completed.

A.0 35.2 2002-2 B Definition of Authorized User

The State failed to include specific

references to requirement

equivalent to 35.392 & 35.394. 

These requirements are related to

training issues and should be

resolved when Rhode Island revises

their training requirements.

The State should include revision of

the training requirements and

inclusion of these requirements in

their regulations when they

incorporate the Part 35 T&E

changes.
STATE REGULATION STATUS

State: Rhode Island 11 amendments reviewed are identified by a  Tracking 

 at the beginning of each equivalent NRC regulation. Date: 05/

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’s

Instructions-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  10 CFR Part 71: Compatibility with the International Atomic Energy Agency-Part

71

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

1996-1 P-Y

ML040760420

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 

 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials;

Clean Air Act-Part 20

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

ML040760420

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 

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

ML040760420

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

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

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

(2/12/01)

1998-1 P-N

ML040760420

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

63 FR 29535; (none) 1998-2 

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 Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1 
NRC Chronology Identification FR Notice

(Date Due for State Implementation))

RATS ID Proposed (P) /

Final (F)1 Rule 

ML #4

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

ML040760420

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

ML040760420

 Financial Assurance for Materials Licensees 

– Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1 P-Y

ML040760420

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 

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

1995.

5. ADAMS ML Number

Requirements for Those Who Possess Certain Industrial Devices ContainingByproduct Material to Provide Requested Information-Part 31

64 FR 42269; (none) 1999-2 

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

(2/2/03)

1999-3 P-N

ML040760420

 Energy Compensation Sources for Well Logging and Other Regulatory

Clarifications-Part 39

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

ML040760420

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

ML040760420

 Requirements for Certain Generally Licensed Industrial Devices Containing 

Byproduct Material - Parts 30, 31, 32

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

ML040760420