July 9, 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: 

Thank you for your participation in the June 16, 2004 teleconference with John Zabko, of my

staff, to discuss the Nuclear Regulatory Commission (NRC) comments on proposed changes to

the Rhode Island regulations and other items contained in your June 4, 2004 letter. Changes in

our review procedures to improve efficiency and effectiveness, as well as collegial interactions

between the Agreement States and the Office of State and Tribal programs, have helped to

make our redesigned, regulation review program a success.

The purpose of this correspondence is to respond to your letter and to summarize the NRC

actions and Rhode Island proposed actions resulting from the teleconference. As discussed

during the teleconference, we agree with your plans for addressing the comments in our May 4,

2004 letter. We believe that we addressed all of your items of concern and that the actions

documented in the enclosed summary, both NRC’s withdrawal of comments and Rhode Island’s

proposed actions resolve issues related to the regulation review. 

If we have misunderstood or mis-characterized your planned actions, please contact me so that

we can ensure that the comments on your draft regulations are adequately addressed. In

addition, we will pursue the items of non-compatibility identified in Part T of the Suggested

State Regulations, with the Part T committee chair and CRCPD.

The additional item discussed in the call, credit for adopting the amendment, RATS ID # 1997-2

“Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within

an Agreement State”, is under review. We will provide you with the results of that review when

completed. 

If you have any questions regarding the enclosure, the compatibility 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 J.M. Piccone\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosure: 

As stated
July 9, 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: 

Thank you for your participation in the June 16, 2004 teleconference with John Zabko, of my

staff, to discuss the Nuclear Regulatory Commission (NRC) comments on proposed changes to

the Rhode Island regulations and other items contained in your June 4, 2004 letter. Changes in

our review procedures to improve efficiency and effectiveness, as well as collegial interactions

between the Agreement States and the Office of State and Tribal programs, have helped to

make our redesigned, regulation review program a success.

The purpose of this correspondence is to respond to your letter and to summarize the NRC

actions and Rhode Island proposed actions resulting from the teleconference. As discussed

during the teleconference, we agree with your plans for addressing the comments in our May 4,

2004 letter. We believe that we addressed all of your items of concern and that the actions

documented in the enclosed summary, both NRC’s withdrawal of comments and Rhode Island’s

proposed actions resolve issues related to the regulation review. 

If we have misunderstood or mischaracterized your planned actions, please contact me so that

we can ensure that the comments on your draft regulations are adequately addressed. In

addition, we will pursue the items of non-compatibility identified in Part T of the Suggested

State Regulations, with the Part T committee chair and CRCPD.

The additional item discussed in the call, credit for adopting the amendment, RATS ID # 1997-2

“Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within

an Agreement State”, is under review. We will provide you with the results of that review when

completed. 

If you have any questions regarding the enclosure, the compatibility 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 J.M. Piccone\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosure: As stated

Distribution:

DIR RF [4-142] Rhode Island DCD PDR (YES_) DWhite RSAO

DSollenberger, ASPO Response to Incoming Document: ML041590261 Rhode Island File

DOCUMENT NAME: C:\ORPCheckout\FileNET\ML041910358.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:DD

NAME JZabko JPiccone

DATE 07/09/04* 07/09/04*

ML041910358 OFFICIAL RECORD COPY
1

SUMMARY OF PROPOSED ACTIONS FROM THE JUNE 16, 2004 TELECONFERENCE

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 49CFR173.401,

in it’s radiological rules, which includes these

definitions.

Rhode Island Action:

The State will incorporate part (a) and (b) of

this comment into its regulations, but will wait

until their next transportation rule revision so

as to engage in only one rulemaking.
2

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.”

Rhode Island Action:

The State will submit this change as a

technical correction to this current rule

making.

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 NRC approved

Quality Assurance Program in sections C.7.6

- C.7.11. to meet this requirement as stated in

71.12 - 71.20

Rhode Island Action:

The State will incorporate this comment into

its regulations, but will wait until their next

transportation rule revision so as to engage in

only one rulemaking.
3

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.

Rhode Island Action:

The State will submit this change as a

technical correction to this current rule

making.

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.”

Rhode Island Action:

The State will incorporate this comment into

its regulations, but will wait until their next

transportation rule revision so as to engage in

only one rulemaking
4

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

Rhode Island Action:

None, this comment has been withdrawn. 

The word “package” is defined as the

packaging and the radioactive material inside

per 10CFR71. Therefor the phrase, “with its

contents” is redundant in 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).

Rhode Island Action:

See Rhode Island action in comment 3. The

addition of the requirement for an NRC

approved QA program in sections C.7.6 -

C.7.11 will adequately address this comment.
5

8 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 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 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. 

Rhode Island Action:

The State will reevaluate its financial

assurance and decommissioning

requirements for source material licensees for

compatibility with 40.36 and 40.42. Due to

the small number of licensees involved, the

State may use license conditions or conduct a

full rulemaking to ensure compatibility. The

State will begin the license condition process

as soon as possible and will include this item

in their next regularly scheduled rulemaking if

they choose the rulemaking option.
6

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.

Rhode Island Action:

The State actions in response to comment #8

will also address this comment.

10 A.2.3 20.1201 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

Rhode Island Action:

The State will submit this change as a

technical correction to this current rule

making.
7