ML23156A072

PRM-150-003 - 59FR50706 - Measurex Corporation: Petition for Rulemaking

ML23156A072
Person / Time
Issue date:	10/05/1994
From:	NRC/SECY
To:
References
59FR50706, PRM-150-003
Download: ML23156A072 (1)

Text

DOCUMENT DATE:

TITLE:

CASE

REFERENCE:

KEYWORD:

ADAMS Template: SECY-067 10/05/1994 PRM-150-003 - 59FR50706 - MEASUREX CORPORATION:

PETITION FOR RULEMAKING PRM-150-003 59FR50706 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE:

PRM-150-003 OPEN ITEM (Y/N) N RULE NAME:

MEASUREX CORPORATION:

PETITION FOR RULEMAKING PROPOSED RULE FED REG CITE:

59FR50706 PROPOSED RULE PUBLICATION DATE:

10/05/94 ORIGINAL DATE FOR COMMENTS: 12/19/94 NUMBER OF COMMENTS:

EXTENSION DATE:

I I

17 FINAL RULE FED. REG. CITE: 61FR01857 FINAL RULE PUBLICATION DATE: 01/24/96 NOTES ON PETITION WOULD HAVE NRC AMEND REGULATIONS ON AGREEMENT STATES TOR TATUS EQUIRE NOTIFICATION TO NRC AND PUBLICATION OF STATE PROPOSED AND C OF RULE OMPLETED RULEMAKINGS AND REGULATORY ACTIONS.

FILE ON 16H.

TO FIND THE STAFF CONTACT OR VIEW THE RULEMAKING HISTORY PRESS PAGE DOWN KEY HISTORY OF THE RULE PART AFFECTED: PRM-150-003 RULE TITLE:

MEASUREX CORPORATION:

PETITION FOR RULEMAKING PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER:

SRM DATE:

I I

SIGNED BY SECRETARY:

09/03/94 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER:

SRM DATE:

I I

SIGNED BY SECRETARY:

12/26/95 STAFF CONTACTS ON THE RULE CONTACT1: MICHAEL T. LESAR MAIL STOP: T-6D-59 PHONE: 415-7163 CONTACT2:

MAIL STOP:

PHONE:

DOCKET NO. PRM-15O-OO3

{59FR5O706)

In the Matter of MEASUREX CORPORATION:

PETITION FOR RULEMAKING DATE DOCKETED DATE OF DOCUMENT TITLE OR DESCRIPTION OF DOCUMENT

04/12/94 04/07/94 PETITION FOR RULEMAKING SUBMITTED BY THE MEASUREX CORPORATION 10/03/94 09/30/94 FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAKING 11/04/94 10/24/94 COMMENT OF ABB INDUSTRIAL SYSTEMS, INC (JOHN R. DUKES) (

1) 11/08/94 11/04/94 COMMENT OF OREGON DEPARTMENT OF HUMAN RESOURCES (RAY D. PARIS) (

2) 11/18/94 11/14/94 COMMENT OF LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY (WILLIAM H. SPELL) (

3) 12/08/94 11/29/94 COMMENT OF KENTUCKY CABINET FOR HUMAN RESOURCES 12/09/94 12/12/94 12/13/94 12/16/94 (VICKI D. JEFFS) (

4) 12/01/94 COMMENT OF GEORGIA DEPARTMENT OF NATURAL RESOURCES (THOMAS E. HILL) (

5) 12/05/94 COMMENT OF 3M HEALTH PHYSICS SERVICES (ROBERT G. WISSINK, MANAGER) (

6) 12/07/94 COMMENT OF KANSAS, STATE OF (GERALD W. ALLEN) (

12/07 /94 COMMENT OF WASHINGTON DEPARTMENT O.F HEALTH (TERRY C. FRAZEE) (

8)

7) 12/06/94 COMMENT OF NDC SYSTEMS (DANIEL FISHMAN, PRESIDENT) (

COMMENT OF A.N. TSCHAECHE (

10)

9) 12/19/94 12/19/94 12/19/94 12/13/94 12/15/94 COMMENT OF COLORADO, STATE OF (ROBERT M. QUILLIN) (

11) 12/19/94 12/19/94 12/16/94 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY 12/17 /94 (THOMAS W. ORTCIGER, DIRECTOR) (

12)

COMMENT OF OHIO CITIZENS FOR RESPONSIBLE ENERGY, INC (SUSAN L. HIATT, DIRECTOR) (

13)

DOCKET NO. PRM-150-003 (59FR50706)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 12/21/94 12/19/94 COMMENT OF ARKANSAS DEPARTMENT OF HEALTH (GRETA J. DICUS) (

14) 12/22/94 12/19/94 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS/SOC NUC MED (WILLIAM H. MCCARTNEY) (

15) 12/27/94 12/21/94 COMMENT OF AMERSHAM HOLDINGS, INC 02/13/95 01/16/96 02/07/95 (DR. BRYAN W. BAKER) (

16)

COMMENT OF TEXAS BUREAU OF RADIATION CONTROL (RICHARD A. RATLIFF, P.E., CHIEF) (

17) 12/26/95 FEDERAL REGISTER NOTICE:

DENIAL OF PETITION FOR RULEMAKING

L __ -

DOCK ETED USNRC

.96 JAN 16 P 1 :30 OFFIC E. Or" SECRElAR Y 0 0 CKE fl r1 G &.,.. c RV I CE

[7590-01-P]

NUCLEAR REGULATORY coMf.fis ION DOCKET NUMBER 10 CFR Parts 2 and 150

[Docket No. PRM-150-3]

PETITION RULE PRU

_ 3 (SQ, F~ 5 O_il_O_lo~~

Measurex Corporation; Denial of Petition for Rulemaking AGENCY:

Nuclear Regulatory Commission.

ACTION:

Denial of petition for rulemaking.

SUMMARY

The Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking submitted by the Measurex Corporation.

The petition was docketed by the Commission, and was assigned Docket No. PRM-150-3.

The petitioner requested that the NRC amend its regulations concerning Agreement State regulation of byproduct material to require Agreement States to notify the NRC of proposed and completed regulatory actions and to require that the NRC publish notices of Agreement States' proposed and completed rulemakings.

The NRC is denying the petition because there would be no safety benefit by NRC actions to consolidate and further disseminate this information; the process of collecting and disseminating this information would place a significant administrative and economic burden on the NRC and the Agreement States; and the information sought by the petitioner on proposed and completed Agreement State rulemakings is already available from a number of sources.

ADDRESSES:

Copies of the petition for rulemaking, the public comments received, the petitioner's response to these comments, the NRC's letter of denial to the petitioner, and the Congressional letters are available for public inspection or copying in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Tony DiPalo, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, T9F31, Washington, DC 20555-0001.

Telephone:

301-415-6191.

SUPPLEMENTARY INFORMATION:

Background

The Nuclear Regulatory Commission (NRC} received a petition for rulemaking dated April 7, 1994, submitted by Ms. Elsa Nimmo for the Measurex Corporation, a manufacturer, distributor, and supplier of services for process control sensors used by NRC and Agreement State licensees throughout the United States.

The petition was docketed as PRM-150-3 on April 12, 1994.

The NRC published a notice that announced the receipt of the petition and requested public comment on the suggested amendments in the Federal Register of October 5, 1994 (59 FR 50706).

The petitioner requested that the NRC amend its regulations in 10 CFR Part 150 that concern Agreement State regulation of byproduct material. Specifically, the petitioner sought an 2

amendment to 10 CFR 150.31 that would have required each Agreement State to notify the NRC of proposed and completed changes to that State's regulations.

The petitioner also sought an amendment to 10 CFR Part 2 that would have required the NRC to publish notices of these regulatory changes in the Federal Register.

The petitioner noted that current NRC requirements contained in

§§ 2.804 through 2.807 of Title 10 of the Code of Federal Regulations establish a procedure for the publication of proposed changes, participation by interested persons, and notification of changes; however, the petitioner believes that a less detailed set of rulemaking and notification procedures is specified in 10 CFR 150.31.

The petitioner also states that, in their experience, the 10 CFR 150.31 rulemaking and notification procedure fails to provide a mechanism for persons located outside any particular Agreement State to learn about proposed changes in that State's regulations.

In the absence of such a mechanism, the petitioner believes that they and others are excluded from the opportunity clearly intended by 10 CFR 150.31 to participate in discussion of the proposed rules.

The petitioner indicated that although it makes a substantial effort to learn about proposed regulatory changes and to maintain current copies of NRC and Agreement State regulations, it is not always notified of actual changes that may directly affect it and its customers in the Agreement States.

For example, the Petitioner noted that under both its specific license for device distribution issued by the Agreement State of California, and the general license issued by other Agreement States, it is required to provide generally licensed device recipients with a copy of the applicable Agreement State 3

regulations.

The petitioner believed that the proposed amendments to 10 CFR Parts 2 and 150 would alert the NRC and Agreement State licensees of all relevant Agreement State requirements ?nd permit them to more fully participate in the rulemaking process.

Discussion of the Petition The petitioner's primary concern is that it and other NRC licensees are not always notified of proposed and completed changes in Agreement State regulations that may affect licensees and their customers in those Agreement States.

The petitioner is also concerned that because it is often not aware of Agreement State regulatory actions, it does not have the opportunity to fully participate in the rulemaking process as is intended by NRC regulations.

As part of the petition for rulemaking, the petitioner included copies of correspondence with Agreement State radiation control boards and the NRC, and cited specific cases with the Agreement States of Oregon and Texas that it believed illustrated why the current rules are deficient and in need of revision.

In Oregon, for example, regulatory changes were proposed that would have eliminated the general license authorizing the petitioner to install, transfer, demonstrate, or provide service and would require the petitioner to obtain a specific license from Oregon in order to conduct business.

These regulatory changes were never approved.

Nevertheless, the petitioner states that had Oregon's proposed regulations been adopted, it would be able to ship sensors to a customer in Oregon only after confirming that the customer has an 4

appropriate specific license.

The petitioner was concerned that interested parties were not provided ample opportunity to comment on Oregon's proposed rules or to participate in their rulemaking process.

The petitioner felt that although it attempted to learn about any proposed or adopted regulatory changes by writing to the Oregon Radiation Control Section on several occasions (between June 1991 and January 1994), it did not receive a response.

Lack of response led the petitioner to believe that Oregon had not modified its 1987 radiological control regulations even though the current version of the Oregon Administrative Rules for the Control of Radiation was adopted in 1991.

The petitioner indicated that it only became aware of the proposed changes to Oregon's regulations in February 1994 when informally contacted by an out-of-state health physics colleague.

In the case of Texas, the petitioner indicated that they did not learn about certain regulatory modifications adopted in 1993 by the Agreement State of Texas until after these rules became effective.

At that time, the petitioner believed that the involved agency, in this case the Texas Department of Health, Division of licensing, Registration and Standards, Bureau of Radiation Control, knew these changes would affect out-of-State firms since the petitioner was notified in writing by this agency in September 1993 about some of the changes after they had been adopted.

However, the petitioner felt they had no opportunity to participate in the rulemaking process and also believed these regulatory modifications would directly affect its business in Texas.

The petitioner noted that some State's radiation control agencies are conscientious in notifying out-of-state distributors or service groups about 5

proposed and completed regulatory changes, but many do not make such an effort.

For these reasons, the petitioner indicated that it and other similar service groups have no way of knowing when copies of a State's regulations are no longer valid and, consequently, have no opportunity to participate in the rulemaking process.

The petitioner also felt that its effort to gain information regarding Agreement State regulatory changes was costly, time-consuming, and often ineffective.

To alleviate this situation, the petitioner proposed that 10 CFR 150.31 be amended to require Agreement States to notify the NRC of both proposed and compl~ted regulatory actions to adopt, amend, or repeal regulations and that 10 CFR Part 2 be amended to require the NRC to publish Agreement State notices of proposed and completed rulemakings in the Federal Register.

However, with regard to 10 CFR 150.31 the staff noted that this requirement applies only to AEA 11 (e) 2 byproduct material (Uranium Mill Tailings) rather than regular "Byproduct Materials."

Summary of Public Comments The October 5, 1994, Notice of receipt invited interested parties to submit written comments concerning the petition.

The NRC received 17 comment letters. Ten comment letters were received from States represented by their Departments of Health, Natural Resources, Environmental Quality, and Nuclear Safety; 4 came from industry representing distributors and suppliers of services for individual process measurement systems; 1 from a private 6

consultant, 1 from a citizens group, and 1 joint comment representing two professional groups.

The petition proposed two amendments.

The first was to amend 10 CFR 150.31 to (in most cases) require Agreement States to notify the NRC of both proposed and completed action to adopt, amend, or repeal regulations.

The second was to amend 10 CFR Part 2 to require the NRC to publish in the Federal Register the Agreement State Notices of proposed and completed rulemakings.

Of the 17 comments received, 11 opposed the petition, 5 favored granting the petition through rulemaking, and 1 supported the petition's request but, preferred a simpler approach as an alternative to rulemaking.

The commenters opposed to the petition did so on the following basis:

(i) A State respondent indicated that its State properly and routinely notifies the NRC of proposed and completed regulatory actions at both the headquarters and regional level.

The respondent also indicated that its State routinely seeks comments from the NRC before promulgation of a State regulation to ensure the NRC is aware of these revisions.

(ii) A State respondent cited an example given by the petitioner of a misunderstanding about notification of a proposed rule the State was developing that was successfully resolved.

The respondent indicated that the State not only gave the party involved (in this case the Measurex Corporation) the information requested, but the comment period was extended to allow the petitioner time to formulate comments for submittal to the Oregon State Public Hearing Officer.

The petitioner's comments were reflected in the final rule.

Oregon has modified its computerized mailing lists and, in the future, the petitioner will receive routine mailings of all regulatory notices.

7

(iii) A State respondent indicated that it can be safely assumed that all Agreement States have some minimum notice requirement for the purpose of due process, and that seeking local relief is far preferable to a national rule. Therefore, if the petitioner has a problem with the due process requirements of a particular State, relief lies with that State's officials and the State's legislative/political process.

Along this line, several State respondents indicated that they have their own laws and administrative procedures which they follow for rulemaking.

Under these requirements, Agreement States maintain registers in which proposed and completed regulations are published and to which interested parties can subscribe.

One State commenter noted that under its public records law it is required to make copies available on request of its proposed and completed regulations.

Another State respondent indicated that the name, address, and telephone number of Agreement State officials can be found in the Conference of Radiation Control Program Directors' Directory of Personnel Responsible for Radiological Health Programs.

(iv) One State respondent indicated that under its Administrative Procedure Act it is required to notify interested parties of rule changes and to hold public hearings to receive comments which can also be delivered in writing.

(v)

A joint response from two professional groups indicated they were concerned with the rising cost of doing business with both the NRC and the Agreement States and therefore, were opposed to any effort that would effect further increases.

They believed the information requests of the petition reflect the cost of doing business with the various Agreement States and that the petitioner should utilize its own resources in gathering the information 8

necessary to become aware of a State's relevant requirements.

One State respondent indicated that the petition would increase costs to State and Federal Governments and to those they regulate because Agreement States and the NRC obtain revenues from fees and/or general fund monies.

Thus, the cost of promulgating proposed State regulations in the Federal Register will ultimately be borne by all radioactive material licensees and the general public.

Because this expenditure will only benefit a small number of service groups that distribute generally licensed devices, it would be more economical if these groups requested copies of the desired information from the States within which they plan to do business.

A State respondent indicated that the cost to the petitioner for producing a periodic form letter and postage would be small compared to the added bureaucracy if the NRC was required to develop a program to gather the desired information from the Agreement States and publish it in the Federal Register.

(vi) Several State respondents expressed concern over the additional administrative and economic burden that would be imposed on the Agreement 9

States because of proposed new procedural requirements in the petition.

Furthermore, these proposed requirements may create conflict with existing State statutes concerning rulemaking time frames, or may further delay an already lengthy rulemaking process.

One State respondent indicated that it was doubtful that their State General Assembly would consider an amendment to a State statute that only accommodates one agency.

The commenters favoring the petition did so on the following basis:

(i) One industry respondent indicated that some Agreement States maintain an effective communication program of notifying interested parties of 9

proposed and completed regulatory actions in their States, but others may not.

Thus, companies like the petitioner's must make a substantial effort to acquire the desired information. Another industry respondent indicated it had difficulty obtaining copies of current regulations and any information on proposed regulatory changes from some Agreement States.

(ii)

An industry respondent indicated that early notification of potential revisions in Agreement State regulations would alert the NRC to possible rule inconsistencies and non-compatibility problems before changes become final, which would facilitate a greater awareness and understanding of the changes.

(iii) A public interest group expressed concern that the difficulties encountered by the petitioner may stem from State government favoritism toward in-State businesses to the detriment of out-of-State entities who are affected by the State's actions.

(iv)

One respondent, a private consultant, indicated that without a mechanism for learning about proposed and completed regulatory actions in Agreement States, it was too time consuming and expensive for individuals to obtain this information.

(v)

One industry respondent indicated that although there were a number of ways interested parties could obtain the desired regulatory information requested by the petition, they did not assume that these parties would be informed.

In addition, it is believed there is a lack of uniformity and consistency among the Agreement States in how interested parties are notified of proposed and completed regulations.

This respondent, while supporting the petition, indicated he preferred a simpler solution (unspecified) for providing uniform and timely information to parties interested in Agreement 10

State regulations.

He also believed the Organization of Agreement States was in the best position to develop such a solution.

Reasons For Denial The NRC reviewed the amendments proposed in the petition, considered the comments received, and concluded that the arguments made by the petitioner are not sufficient to warrant amending 10 CFR Parts 2 and 150.

The reasons for denial are as follows:

1.

The petition does not discuss any situation in which the public health and safety is an issue or any apparent safety benefit that will be derived by collecting and disseminating the information requested by the petition. Thus, the NRC foresees no basis for the additional administrative burden or increased costs to collect and disseminate this information in the manner suggested by the petition.

2.

The process of collecting and disseminating the information pursuant 9

to the petition would place an administrative and economic burden on both the NRC and Agreement States.

The petitioner did not address the costs for developing the information system that would be necessary to implement the proposed amendments in the petition or consider the reporting burdens that would be imposed on both the Agreement States and the NRC to support the operation of such a system.

The petitioner did not consider the costs associated with system operational problems, the need for additional staff resources at both the NRC and Agreement States, the need for administrative procedures for tracking information and documentation system instructions, and 11

the costs for periodically publishing notices of the information under NRC auspices in the Federal Register.

3.

The information sought by the petitioner is already available through other mechanisms.

Based on a review of the public comments, several means presently exist by which interested parties who are not licensed in a particular Agreement State can access information on proposed or completed regulation changes in a particular Agreement State.

As previously mentioned, several Agreement State respondents indicated that, as required by State statute, they maintain state registers in whicfl proposed and completed regulatory actions of that State are published.

The information on the State Registers is available to interested parties on a subscription basis, by mail, or by telephone.

The Conference of Radiation Control Program Directors, Inc., also maintains a directory that includes the name, address, and telephone number of Agreement State public officials responsible for radiological health programs.

By making a telephone call to the appropriate Agreement State public official, a requester can obtain information about the latest proposed and completed regulatory actions in that State.

In addition, the NRC maintains a list of Agreement State contacts that includes telephone and facsimile numbers and addresses.

Interested parties can call or write to the NRC to obtain this information.

The NRC also sponsors open meetings twice a year to discuss Agreement State and NRC regulatory matters.

12

Because of the potential administrative burden and added costs a~sociated with the development and operation of an information system to support the requests in the petition without an accompanying health and safety benefit, and because alternative means are currently available to the petitioner and interested parties to acquire the desired information about Agreement State regulatory activities, the petition for rulemaking filed by the Measurex Corporation (PRM-150-3) is denied.

Dated at Rockville, Maryland, this ~day of~, 1995.

For the Nuclear Regulatory Commission.

H L. Thompson,

r.

Acting Executive Direc 13

DOC r:lEO US. RC Texas Department of Health

• 95 FEB 13 A 1G :36 David R. Smith, M.D.

Commissioner February 7, 1995 Secretary A TIN: Docketing and Service Branch U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Secretary:

1100 West 49th Street Austin, Texas 78756-3189 (512) 458-7111 Radiation Control (512) 834-6688 Carol S. Daniels Deputy Commissi9ner for ~ram y OF FIC.-(1

{__t...'

• 1w,'

Roy LQOOi(ifu T.,

Deputy Commisst9~er fQi:.:A1dministration Re: Docket No. PRM-150-3 These comments are in response to a petition for rulemaking in which the petitioner requests that NRC require Agreement States to notify NRC of all proposed and completed regulatory actions and that NRC publish such notices of Agreement States' rulemaking. While these comments are being submitted after the comment deadline, we hope they will be given consideration.

The Bureau of Radiation Control (BRC) opposes this petition and wishes to reiterate many of the same reasons the state of Washington cited in its opposition to the petition.

The Texas Government Code sets forth the procedures that we must follow in the adoption of any rule. It involves publication of the rule in the Texas Register with at least 30 days for public comment. In addition, the BRC maintains interested persons mailing lists and distributes drafts of rule revisions to those persons in order to obtain early input to the rulemaking process. This process of mailing drafts is not required, but we

~eel it is a method of facilitating communication with those we regulate. The NRC is one of those entities to 9,vhich we mail draft, proposed, and final rules.

Also, by the end of 1995, the BRC will have the capability of posting draft and proposed rule revisions on an electronic bulletin board system to further facilitate communication. This represents an additional method of addressing the petitioner's concern, communication of rule changes.

We oppose any petition that proposes requirements that may be in conflict with existing state statutes concerning rulemaking time frames or that may further delay an already lengthy rulemaking process. However, we see no problem if the NRC wishes to publish informational notices of Agreement State rulemaking. As did the state of Washington, we recommend the petitioner develop a working relationship with the individual Agreement States.

Thank you for the opportunity to provide input. If you have any questions, please contact me at (512) 834-6688.

Sincerely,

~

tliff

.E., Chief Bureau of Radiation Control I\\ ~ \\~~';)

-~'-

Acknowledged by card......... _............... --~

An Equal Employment Opponunity Empluyer

U.S. NUCLEAR REGULATORY COMMISSIO~

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Doci rrnent Statistics Postmark Date $¥;--r-,__ ___ _

Co~es Recei

~ -----

Add'I Copies Repr J

~

S~ecial Dis'*ibutio '7?1:>12.. 1::R,(b~

December 21, 1994 U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, Maryland 20852 Attn: Docketing and Service Branch Re:

Petition Docket PR7-150-3 DOCKETED US RC

• 94 O[C 27 P 4 :25 OFFICE ( r ~~1*r ~- M rr amHoldings,lnc.

DOC KE ( r< { ' 2636 s. Clearbrook Drive 81-<1-d/l'I-{ *Arlington Heighrs, IL 60005 tel (708) 593-6300

,..Amersham

'J/.1,* 1/e,,/t/J \\cie11 a

(,"rrJ11/1 I am writing on behalf of Amersham Holdings to support the above petition submitted to the USNRC by Measurex Corporation and published in the Federal Register, Vol 59 No 192 Wednesday, October 5, 1994, pgs 50706-50708. We are completely in agreement with the principle that there needs to be a mechanism for NRC to notify distributors of radioactive material of proposed and completed changes to Agreement State regulations, by publishing them in the Federal Register.

Furthermore, although I realize that the USNRC does not currently have jurisdiction over NARM, information on states' proposed changes to the regulations of those materials also needs to be disseminated through publication in the Federal Register. We defer to the USNRC as to the regulations that need amendment to insure that these publications occur.

Amersham finds it very difficult to obtain copies of current regulations from some Agreement States, and much more so to obtain any information on proposed changes. It was a phone call from Measurex that alerted us to the proposed changes in the Oregon regulations, otherwise we would not have known about them. Those proposed changes would have virtually precluded the distribution of generally licensed devices, including Amersham Static Eliminators, within the state of Oregon.

The state had not appreciated the implications of the proposed changes and fortunately did not implement them after they were made aware of the consequences of th~ proposed changes.

Medi-Physics, Amersham Healthcare is also finding it difficult to keep abreast of Agreement States licensing requirements for the use of Metastron (Strontium-89) for the relief of pain in patients with bone cancer.

These are just two recent examples of the problems we have experienced from the difficulties in keeping current with the Agreement State and Registration State regulations.

lffi\\ '2 4 1995 Acknowledged by card................................

l).S. UCL.:.

'. * **.., !J,-i'f coM~.\\ISSION oou.e :.. :, & -,EJW\\CE SECTION Off 1C.c OF THE SECRET ARY OF THE COM i\\SS10N Ocwrne:11 S~atistics strnarl< DstP-J.?-1-:;._/ I ll'-1

?le~ Rece1*1cd ___ ~/ _ ___ _

ct*1C0 1

,\\e P.~prw...

j }_

C

.J'.l! ~;S' 1-\\_,,v1 ~

()5, fJYJ~

~

U.S. Nuclear Regulatory Commission December 21, 1994 Page 2.

In summary, Arnersham does support the Measurex petition but defers to the USNRC as far as which regulations require amendment.

Please let me know should you have any questions concerning this topic. I shall be pleased to discuss this with you and may be reached by phone at 708/593-6300, extension 379.

Corporate Manager, Nuclear Licensing and Industrial Liaison BWB:bcb

DOCKET NUMBER PETITIO PULE PRM /.5Cl- ~

~

fA'(rLOOD1 ___ _ _ __ ~_.s_c;_F_~_s___;;t9:;__7o___;_~_u ___ ~ll'fll lJV

~

1200 19th Street, N.W.

• Suite 300

• Washington, D.C. 20036-2401 ~llAJ American (202) 429-5120 College of Nuclear Physicians December 19, 1994 John C. Hoyle Acting Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch "94 Fax (202) 223-4579 The Society of Nuclear OOCKEl EO Medicine USNRC

'"' 22 A1C :46 RE:

Petition for Rulemaking filed by Measurex Corporation; 10 CFR Parts 2 and 150; Wednesday, October 5, 1994; 59 Federal Register 50706.

Dear Secretary Hoyle:

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) are writing in opposition to the above mentioned petition1* While the ACNP and SNM are in favor of an open public comment process, we feel that the Agreement States should not be forced to expand their current access to public comments. The ACNP and SNM remain concerned about the rising cost of doing business with both the NRC and the Agreement States, and are against any effort that unnecessarily raises that cost.

It is our feeling that the information requested by the petitioner simply reflects the cost of doing business with different states. The Nuclear Regulatory Commission should not impose administrative requirements that are not cmrently applied to other industries outside of the nuclear field. Measurex should utilize its own resources in gathering information about the regulatory process in the 29 Agreement States and not depend on a federal mandate to facilitate its information gathering operation. There is ample opportunity for public comment within an individual state's regulatory process, and this issue revolves around the ability to gather that information.

In addition, to require the Agreement States to notify the NRC of all regulatory action is beyond the mandate of the Nuclear Regulatory Commission. The NRC must approach the Agreement State program through the concept of co-regulators. Notification of rulemaking simply places additional financial burden on the states and discourages states from developing their own individual programs.

In conclusion, ACNP and SNM would like to reiterate that we are opposed to both of the petitioner's requests and urge the NRC to deny this petition.

w~~-~w, William H. McCartney, M.D.

President American College of Nuclear Physicians Sincerely, James J. Conway, M.D.

President Society of Nuclear Medicine 1 The American College of Nuclear Physicians and the Society of Nuclear Medicine represent over 15,000 nuclear physicians, nuclear phannacists, nuclear scientists, and nuclear medicine technologists, involved in the delivery of essential health care.

ifm 2 4 i99o Acknowledged by card.......................... *.,

V

• I I sv.i. I UI-\\

\\J o:) ;,<'.:T,N"' & SERV!Cf S C t01J OFf ICE OF THE SEC f 1 ARY OF THE COMM!S<:'./J Document St. Ii l!:.S Postmark Date I~ '2---/

CoplQs Received I

Add'I Copies Rep-oduCOO 3 ---

s::~~

12'_153

DEC 19 '94 1S!S2 TO 301 492 4275 FROMDOCKET NUMBER T-484 P. 02 PETITION RULE PRM \\50-~

( 5~ FR..5C'7cioJ

~

DEPARTMENT OF Rg~!fJ 4815 WEST MARKHAM STREET* LITTLE ROCK, ARKANSAS 72205-3867 TELEPHONE AC S01 661-2000 JIM GUY TUCKER GOVERNOR Secretary.

u.s. nuclear Regulatory Comm1ss1on Hashtngton, D.c. 20555 SANDRA B. NICHOLS, M.O.

DIRECTOR ATTENTION:

Docket1ng and Service Branch

• 94 DEC 21 A 9 :29 O

J..-;--'

,~

'r- '--*~

DOC! C December lQ, 1994 RE:

Measurex Corporation. Receipt of a Pet1tion for Rul@making To the Conmiss1on:

Hhtle Measurex's concerns may be va11d, Arkansas Radiation Control disagrees wtth the propos@d solutlon.

We generally support the position taken by the State of Washington in Terry Frazee's letter to the NRC dated December 7, 1994 Tho pot1tioner's proposed solution can 1nterfere w1th the adm1n1strat1ve process of rulemaking that state programs must follow.

Also, as Agroement States already subm1t proposed regulat1on changes to the NRC, 1t seems unnecessary to formalfze the process by rule.

(Although not an 1ssue in thci pet1t1on, I am unccrta1n to what extent states subm1t regulation cha11ge-:;

for radiation sources not under the NRC's jur1sd1ct1on.) A more practical solut1on would be for the NRC to use the Federal Regisler, Lt11:1 Regulatory Agenda or some other su1table document to publfsh a state's Intent to rev1se a regulation.

If an affected company has nol already receivect a copy of the proposed change, a request could then be made to the Agreement State.

You should be aware that Arkansas' Adm1n1strat1ve Procedures Act requires us Lo 11ullfy dll affected part1es of rule changes and to hold a publ1c hearing to receive comments.

Comments may also be submttted fn wr1t1ng. It 1s my understanding that this 1s true for most states, further erodtng the need for rulemaking in thts area.

It would appear to us that the problems Measurex has encountered 1n the states ment1oned 1n the pettt1on, may be isolated events that can be best handled admtn1strat1vely.

Thank you for the opportunity to comment on the petition.

Since~. D:~

• H,cus. Director on of Radiation Control

& Emergency Management RAODOC:1348 rfEB 2 4 1995 Acknowledged by card............................... ~

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmar1( Date ~

ta D \\-\\19h~

Copies Received__,_ ______ _

Add'I Copies Reproduced.....;~=-----

S

• a1 Distribution 3 P~ e>.1:>5,,

DOCKET NU BER December 17, 1994 PETlTION RU

!.!.PR,;:!!...,~

--r (S9B2.S0'1D~

COMMENTS OF OHIO CITIZENS FOR RESPONSIBLE ENERGY, C

ON PETITION FOR RULEMAKING, PRM-150-3, 59 FED. REG.

BER 5, 1994)

~

In PRM-150-3, the petitioner, Measurex Corporation, requests that the NRC amend its regulations in 10 CFR Part 150 governing Agreement State regulation of byproduct material to require Agreement States to notify the NRC of all proposed and completed rulemakings.

The petitioner also requests that the NRC amend its regulations in 10 CFR Part 2 to require the NRC to publish Agree-ment State notices of proposed and completed rulemakings in the Federal Register.

OCRE supports this petition for rulemaking.

OCRE finds it de-plorable that the petitioner has had such difficulty obtaining notice of what should be readily available public records.

If a

company has this much trouble trying to become aware of and to participate in Agreement State rulemaking actions, it must be even more difficult for members of the public.

OCRE is also concerned that the difficulties encountered by the petitioner may stem from state government favoritism toward in-state businesses, to the detriment of out-of-state entities who are nonetheless affected by the state's actions.

Such favoritism should have no place in the behavior of a regulatory body.

OCRE finds the comments made at the November 15, 1994 NRC Work-shop on Adequacy and Compatibility of Agreement State Radiation Control Programs by Mr. Aubrey Godwin of Arizona on the avail-ability of state regulations to be rather disturbing:

[Businesses]

"can get a copy for a small fee - of course, some-times it isn't that small - that you do business.

In many cases, they have to appoint an agent within the state to represent them... If a citizen wants to do business before any of our regulatory bodies, they come to us and do it just like the indus-try does.

There's no problem.

If you want to do business with it, you inform yourself how to do it, and then you proceed.

I'm sure the local attorneys would be happy to take your money and lead you right through it."

OCRE would hope that Agreement States are not deliberately creat-ing closed and arcane regulatory systems for the purpose of establishing a local lawyers' full employment program.

The NRC 1

rte 2 4,99S Acknowledged by card............................... ~

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION (

OFFICE Of THE SECRETARY OF THE COMMISSION "i*

Document Statistics

\\

Postmark Date _.\\_,~.,_.\\9_.\\1-9.._i:\\: ___

Copies Received_.......__' ____ _

Adctl Copies Reproduced ---'-3...._ ___ _

SP._ecial Distribution :@e..) '.5IDS, L_

should grant PRM-150-3 to prevent these types of abuses.

OCRE believes that the scope of PRM-150-3 should be expanded to include proposed and enacted state legislation relevant to the Agreement State program.

Many times legislation is passed which gives the implementing agency little choice in adopting regula-tions; i.e., the real chance for interested persons to influence the process is before the legislature.

OCRE would note that it might be more cost-effective, as well as providing more timely notice, for the NRC to establish a comput-er BBS listing the proposed and completed rulemakings of Agree-ment States, rather than publishing them in the Federal Register.

Respectfully submitted, Susan L. Hiatt Director, OCRE 8275 Munson Road Mentor, OH 44060-2406 (216) 255-3158 2

<C"<".

')

'"'."*.... ')

DEPARTM

. R SAFETY **~_:-R 10 @

1

• , E SPRI 162704

• 9.1 ncr* 19 P3 :o9 Jim Edgar Governor Secretary Nuclear Regulatory Commission Washington, D.C. 20555 t

'i:

2 N ='-.,,_~,J,M

,?

'\\, "~-.

~.,:

't.t!{J;:""'

.-,,,__,.* ---.,_.. """',.~-,..,,*

--~.. -:s...~...... '>~>).>

December 16, 1994 Attention:

Docketing and Service Branch Thomas W. Ortciger or I I Director On"' *r u,

DOCKET NUMBER PETITION RULE PRM \\SD-5 --

( 59 ~R. 50 ~ ()~

RE:

Petition for Rulemaking, Docket No. PRM-150-3; 59 Federal Register 50706 (October 5, 1994)

The Illinois Department of Nuclear Safety (Department) hereby submits its comments on the above-referenced petition for rulemaking filed by Measurex Corporation.

The Department believes that publication of all Agreement State regulations in the Federal Register is not a practical method of disseminating information as most states already have a sufficient system of distributing regulatory information within a state.

The 1991 Edition of the "Document Drafting Handbook," issued under the Federal Register Act, 44 U.S.C.A § 1501-1511, and the regulations of the Administrative Committee of the Federal Register (1 CFR 15.10), state that the Federal Register provides a system for publishing Presidential and Federal agency documents.

Rules published by Federal agencies in the Federal Register are eventually incorporated into the Code of Federal Regulations (CFR).

Since Agreement States do not fall under the grouping of a Federal Agency, and since there is no corresponding CFR for Agreement State regulations, there appears to be no mechanism in place for publishing a compilation of all Agreement State regulations.

The petitioner states, in part, that because "there is no current notification procedures for Agreement States," the petitioner does not have ample opportunity to participate in discussion of proposed rules.

This is not an accurate statement of the rulemaking procedures in Illinois, as Illinois has a highly structured process for promulgating rules.

For example, in Illinois, the Department must comply with the provisions of the Illinois Administrative Procedure Act (IAPA), 5 ILCS 100/5 100/5-155, in order to promulgate rules in Illinois.

The IAPA requires that Illinois agencies give at least 45 days' notice of its intended action to the general public.

This initial 45 day period is called first notice.

The proposed rule is published in the Illinois Register which is a publication of E

@ recyclable Acknowledged by card..... :~... ~.. ~... :~::... 0

U.S. tJ'JCLEb,R REGULATORY COMMISSIO DOCKET:NG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Do(,Ul'l8f\\t StatisticS Postmafi< Date __..=,:;o.~,-o\\-~----

Copies Recel\\led_.. ______ _

Add'I Copies Reproduced..::;3==-----

Special Oistrib'JV),1 _3;'.PS2, :&rn:S,,

_sSan,c,n-

Secretary Nuclear Regulatory Commission Page 2 December 16, 1994 all ongoing agency rulemaking.

During first notice all interested parties to the rulemaking may submit written or oral comments to the agency.

Agencies are also required to hold a public hearing during the first notice period if, (1) during the first notice period, the agency finds that a public hearing would facilitate the submission of views and comments that might not otherwise be submitted, or (2) the agency receives a request for a public hearing, within the first 14 days after publication of the notice of proposed rulemaking in the Illinois Register, from 25 interested persons, an association representing at least 100 persons, the Governor, the Joint Committee on Administrative Rules, or a unit of local government that may be affected.

After the first notice period concludes the agency is required to give an additional 45 days' notice to the Joint Committee on Administrative Rules (Joint Committee).

The Joint Committee is a separate entity charged with the function of reviewing agency rulemakings.

The Joint Committee reviews the rules for their propriety, legal adequacy, relation to statutory authorization, economic and budgetary effects, and public policy.

An agency is required to notify the Joint Committee of all proposed changes to the rule and to prepare a final regulatory flexibility analysis containing a summary of issues raised by small businesses.

The agency is also required to submit to the Joint Committee a summary of all written comments received by the agency during the first notice period, and the agency's response to each comment.

The Joint Committee can also ask the agency for an analysis of the economic and budgetary effects of the agency's rulemaking.

The Joint Committee is authorized to hold public meetings to discuss the proposed rulemaking.

A recent amendment to the IAPA requires agencies to provide regulatory agendas for publication in the Illinois Register by January 1 and July 1 of each year.

This provision became effective September 16, 1994.

These regulatory agendas are required on a semi-annual basis in order to elicit public comments concerning any rule which the agency is considering proposing but for which no notice of proposed rulemaking has been submitted.

This is an additional mechanism to apprise interested parties of regulatory changes.

Furthermore, Illinois agencies are under a time constraint with regard to the rulemaking process, as no agency may promulgate a rule more than one year after the date the first notice period commenced.

The proposed requirements in 10 CFR 150.31 (c) and 2.810 requested by the petitioner conflict with Illinois law and duplicate the current procedure for rulemaking in Illinois.

The suggested changes to the NRC rule would require, at a minimum, an amendment to the IAPA.

This is not only burdensome and time consuming but highly infeasible, as the Department is not the only agency subject to the IAPA.

It is doubtful that the Illinois General Assembly

Secretary Nuclear Regulatory Commission Page 3 December 16, 1994 would consider an amendment to a state statute that only accommodates one agency.

Since the Illinois Register is published by the Secretary of State's office, as well as by a private publishing firm, any person doing business in the state of Illinois has access to ongoing rulemaking activity via the Illinois Register.

Doing business in a particular state carries with it the responsibilities of complying with applicable laws and regulations of the state. It is not the state's responsibility to notify affected parties of regulatory changes, as the state is not always aware of the affected parties presence in the state.

It is the duty and obligation of the entity doing business in an Agreement State to be aware of each Agreement State's requirements.

Assuming the NRC were to include Agreement State rules in the Federal Register under the guise of an NRC "Notice, the NRC would have to approve such notices.

It is the Department's understanding that the NRC would not be able to send a document to the Federal Register until the document has gained concurrence from several offices, including the Secretary, the Executive Director for Operations and the Office of General Counsel.

In many cases, Agreement State regulations are not identical to NRC regulations, and concurrence on a particular state's rule would be difficult, if not impossible to obtain.

This would be an infringement on the state's right to promulgate rules necessary to protect the health and safety of the citizens of that state as well as jeopardize a state's ability to promulgate a rulemaking within the allowed time period as Illinois law mandates.

The process of requiring publication of a state rule in the Federal Register would only add more delay to the already time-consuming task of promulgating rules.

The additional delay of requiring rules to be published in the Federal Register before they can become effective may endanger public health and safety in emergency rulemaking proceedings.

Moreover, the narrow focus of the petition on lle(2) byproduct material hardly justifies the additional costs and administrative burdens placed upon the NRC and Agreement States to comply with the petitioner's proposed changes.

The provisions contained in 10 CFR 150.31 were required by the Uranium Mill Tailings Radiation Control Act of 1978, as amended, and relate solely to mill operations and disposal.

The Department recommends that the NRC annually publish a notice in the Federal Register indicating the name, address, phone number and FAX number of an individual in each Agreement State that can be contacted to obtain copies of rules or proposed rules.

This would provide the petitioner with the specific name of the individual responsible for providing copies of regulations to interested parties.

Secretary Nuclear Regulatory Commission Page 4 December 16, 1994 The Department appreciates the opportunity to provide comments on this important issue.

If you have any questions regarding these comments, please contact Ms. Valerie Puccini at 785-9880.

incerel Thomas W.

Director TWO:vap

S_TA_J'_E_O_F-++t"--£+"'>-Por.8

_ MD_ 0_ @

Roy Romer, Governor Patricia A. Nolan, MD, MPH, Executive Director Dedicated to protecting and improving the health and environment of the people of Colorado

• 94 OEC 19 P 2 :14 4300 Cherry Creek Dr. S.

Laboratory Building Denver, Colorado 80222-1530 4210 E. 11th Avenue Phone (303) 692-2000 Denver, Colorado 80220-3716 (303) 691-4700 DEC 15 1~94 Secretary u.s. Nuclear Regulatory Commission Washington, DC 20555 ATTENTION:

Docketing and Service Branch OFF:c-OOC E

~ '._, l) r- -;. ~lorado Department

,., ~ 1

• r of Public Health and Environment DOCKET NUMBER PETITION RULE PRM \\5C-3>

( 6q f=R. SD1 cQ RE:

Docket No. PRM-150-3, Petition for rulemaking by Measurex Corporation This letter is in response to the petition for rulemaking by Measurex Corporation (Measurex).

Colorado believes that the petition by Measurex should be denied because it is not needed; it imposes unnecessary and unproductive burdens upon both the states and the federal government; and it would transcend the NRC's authority by imposing unprecedented national requirements upon states and elevating state procedural matters to a federal level.

GENERAL COMMENT

S:

Petitioner's rule, if adopted, would shift the responsibility of keeping appraised of regulatory changes from Measurex to the state and federal governments.

The asserted basis for petitioner's petition is difficulties it has had with notice of regulations in two states.

It can be safely assumed that all states have some minimum notice requirements for due process purposes.

Therefore, the means to be informed of new regulations already exist.

Measurex's problems with two other states do not justify imposing new and additional burdens upon other states nor upon the U.S. Nuclear Regulatory Commission (NRC).

Petitioner's proposal is unprecedented.

To the best of our knowledge, at least in the area of health and environmental protection, a similar requirement has never been imposed upon states that are authorized to implement national programs.

The same argument could just as easily be made -

but apparently has not been -

for regulations concerning water quality, air quality, mined land reclamation, and hazardous and solid wastes.

The situation Measurex faces is not unusual and not compelling.

It is not clear that procedural problems are the petitioner's motivation for the proposed rule.

For example, Measurex wants Agreement States to inform the NRC of the authority under which the regulation is proposed.

It also wants for any post-promulgation comments received, the Agreement States to submit a statement to the Secretary, NRC that contains an evaluation of significant comments and revisions of the rule made as a result of the comments and their evaluation.

If Measures is simply seeking a mechanism by which it may learn of pending state regulations, these provisions are unnecessary.

l'I ~,~

I~,_

Acknowledged by card.......................... **"*

U.S. NUCLEAR REGULATORY COMMISSIO DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION Document Statistie:S Postmarl( Date..;::s.a,.~~il>J+,-----

Coples Received__,_\\ ______ _

Add'I Coples Reproduced -~------

Special Distribution ::]>DR., &\\ :ns,,

Secretary, U.S. Nuclear Regulatory Commission Docket No. PRM-150-3 Pa e 2 Conspicuously absent from Measurex's petition is any discussion of the cost associated with the proposed new requirements and who will bear those costs.

Agreement States and the NRC will incur additional costs in complying with the new rule.

Measurex evidently expects the states, the NRC and other radioactive materials licensees to bear the cost of assisting it in the conduct of its business.

In an era of shrinking budgets where customers are expected to pay for the service they receive, this proposal in unacceptable.

Measurex states that it has been adversely affected by the current regulations.

It has given examples that relate to increased costs for the company in Texas and Oregon.

It has not demonstrated that the proposed rules in Texas and Oregon would have changed the economic impact for the company had Measurex provided testimony on them.

Further, it has not addressed the merits of the states' proposed rules; whether they were necessary to protect public health and safety, and whether a modification that involved less of an economic burden on Measurex would lessen their health and safety benefit.

SPECIFIC COMMENTS:

1.

The Means Already Exist For Measurex To Obtain Information About Proposed State Regulations.

Measurex has chosen to engage in business on a national level.

It therefore must assume the burdens of doing so.

This includes the burden of keeping itself informed of applicable state requirements.

The means already exist for the petitioner to do so.

That Measurex has not always been successful does not justify imposing national requirements upon all Agreement States.

Measurex's remedy is with state and local officials.

If per chance there is a due process problem with a particular state, Measurex's relief lies with that state's officials and the state's legislative/political process.

Because of the significant negative implications of petitioner's proposed rule discussed below, seeking local relief is far preferable to a national rule as proposed.

2.

The Proposed Regulations Are Inconsistent With The Agreement State Program.

Colorado is not convinced that simply instituting a mechanism to inform companies doing business nationally of proposed state regulations is the true purpose of the petition.

Citing two examples, Measurex candidly also expresses concerns about new regulations being "costly and administratively burdensome."

It thus appears that Measurex wants to bring substantive state issues to a national forum.

This is inconsistent with the Agreement State Program, the very purpose of which is to allow Agreement States, within the confines of the "compatibility" requirement, to tailor programs best suited to their needs.

The criteria for maintaining an Agreement State program is that the program be "compatible" and adequate to protect the health and safety of the citizens within that state.

Maintaining economic viability of a company outside the state is not a requirement.

Secretary, U.S. Nuclear Regulatory Commission Docket No. PRM-150-3 Pa e 3

3.

The Proposed Rule Imposes New and Additional Procedural Requirements Upon States, Thus Creating Conflicts.

Measurex's proposed rule would impose new and different procedural requirements upon Agreement States such as Colorado.

For example, the proposed rule requires a 30 day post-promulgation period if the federalrequirements are deviated from (proposed rule§ 150.3l(c)(2) (v)).

Since no such requirement exists in Colorado, is the action challengeable if not complied with, even though state requirements are satisfied?

Does this challenge occur at the state or federal level?

Clearly, this situation threatens an unwarranted injection of the federal government into a purely state procedural matter.

Similarly, the proposed rule creates a new federal procedural criteria such as the requirement that a state have "good cause" to deviate from the requirements of the rule (proposed rule

§ 150.3l(c) (2)(iv)).

Is the state's determination of "good cause" reviewable?

By NRC?

If not by NRC, what is the authority of a state agency or court to determine compliance with a federal requirement?

Once again, the situation is ripe for conflict and threatens an unnecessary, unwarranted and burdensome injection of federal authority into state procedural matters and may even create litigation.

More fundamentally, however, if the proposal is merely to give Measurex notice and opportunity to participate in the promulgation of state regulations, what purpose is served by requiring the state to inform NRC of the authority under which the state is promulgating the rules?

Measurex can easily obtain this information from the appropriate state agency, and NRC already periodically reviews state programs for "compatibility."

The rule proposed by Measurex raises the specter of Measurex challenging state authority before the NRC-Since an Agreement State by definition must have sufficient authority to implement a "compatible" program, such issues are properly raised at the state, not federal level.

Whether the state has sufficient authority is between the state and NRC; whether the state has authority to promulgate the regulations is between the state and interested persons such as Measurex.

4.

The Proposed Regulation Would Not Solve the Problem To Which Measurex Speaks.

Not all States that promulgate regulations pertaining to radiation control are Agreement States.

Non-Agreement States propose rules that relate to Naturally-Occurring and Accelerator Produced Materials (NARM).

Because NARM is outside the authority of the NRC, the NRC could not publish these regulations.

Measurex would still be affected by these regulations without their having been published in the federal register.

Moreover, it is not clear that notice in the federal register as proposed will rectify any state due process deficiencies that may exist.

5.

The Proposed Regulation Would Increase The Costs To The State And Federal Governments And To Their Licensees Without A Commensurate Benefit.

As noted above, the proposed rule would not solve the problem identified by Measurex, and attempting to solve it as proposed would increase costs to state and federal governments, and to those whom they regulate.

Because Agreement States and the NRC obtain revenues from fees and/or general fund monies, the cost of promulgating proposed state regulations in the federal register will

Secretary, U.S. Nuclear Regulatory Commission Docket No. PRM-150-3 Pa e 4 ultimately be born by all radioactive materials licensees and by the general public.

But this expenditure of funds will only benefit a few companies that distribute generally licensed devices.

If such manufacturers requested copies of applicable state regulations from the states directly, it would be more economical for the regulated community and tax payers, and the manufacturers would have all the information they need.

CONCLUSION:

The means for Measurex to appraise itself of changes in applicable state regulations already exists.

The problems perceived by Measurex can be solved without imposing additional burdens and costs upon the state and federal governments by Measurex exercising more diligence and by asserting its rights in states where due process problems exist, if any.

The solution does not lie with the unprecedented step of imposing national requirements upon Agreement States and elevating state procedural matters to a federal level.

If you have any questions or require additional information, please don not hesitate to contact me at (303) 692-3030.

~~

Robert M. Quillin, Director Radiation Control Division cf:

Richard Bangart Agreement States

13 December, 1994 Secretary U.S. Nuclear regulatory Commission Washington DC 20555 DOCKET NUMBER

,. *~

PETlTlON RULE PAM

\\~~

,,..T..

csq ~R-.5"c'1Db) ooc -_RCD lfo\\

A.N.TSCHAECHE ust

~

1693 CLAREMONT LANE IDAHO FALLS ID 83404

.94 D(( \\ 9 P 2 *., 7 C

r

-cl E ;AP,Y

-,r-t,..

r Of-t\\*.,t *

~,..,R;\\;c_

00 ~ ~ it.Ge: -* 1-l,

~ R' I NC\\-1 Re: Docket PRM-150-3 Attention: Docketing and Service Branch

Dear Sir:

59 FR 50706 requests comments on a petition for rulemaking filed by the Measurex Corporation that has been docketed by the Commission and assigned Docket No., PRM - 150 - 3. I have reviewed the FR citation and offer the following comments for consideration; I. I completely agree with the petition. The Commission should amend its regulations substantially as stated in the petition.

2. In addition to the reasons given by the petitioner, I offer the following in support of the petition:

There are many individuals, myself included, who consult in the field of health physics including NRC, agreement state, and other regulations having to do with radiation protection.

It is time consuming and expensive for such individuals to search out the appropriate state regulations and proposed regulations every time a revision is made to a state regulation. The petition, if granted, would make the consultant's life much easier in this respect.

In addition, consultants occasionally need to comment on proposed state regulations, particularly when those proposed regulations would impact directly on a consultant's livelihood. For example, state regulations may be proposed to be amended to require licensure of consultants in the field of radiation protection (such as recently happened in Texas). Without a central mechanism for learning about such proposed amendments, it is very difficult and expensive for individuals to obtain information about such proposed actions.

Finally, the proposed amendment of 1 0CFR Part 2 would give the Commission itself information about what Agreement states propose to do so that the Commission can comment if appropriate. The Commission can then more easily ensure that the Agreement states' regulations are indeed "comparable" with those of the Commission I trust that these comments are properly responsive to the request and will be happy to supply additional information if necessary.

Very truly yours,

/

}

,. ; / 1 * /c. /!./,,

A.

,I

)

L t ~

/---------

A, N. Tschaeche rm 2 4 1995 Acknowledged by card.......................... :... ~

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Statistics Postmartc Date _\\.a..,~::::\\+.J\\~51-µ.~ ----

Coples Received_,_ _ _____ _

Add'I Copies Reproouced.......,.'---___ _

S ial Distribution ::PDQ, 1 R,\\U'SJ

SYSTEMS 0 C E 0 S RC 730 EAST CYPRESS AVENUE MONROVIA, CALIFORNIA 91016 (8181 358-1871. FAX (8181 303-sno

• 94 r-i9 p 3 :07 December 6, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch

SUBJECT:

Public Comment on Docket# PRM-150-3 DOCKET NUMBER PETITlON RULE PR

\\S0,,;:.3 (5°' ~fe..5D10Co}

I\\1DC Systems is a manufactur *, distributor and supplier of services for process measurement sensors used by NRC and agreement state licensees. We support the petition for rule making, docket # PRM-150-3, submitted by Measurex Corporation.

NDC manufactures, installs and services sensors used by both general and specific licensees throughout the United States, under the specific license for device distribution issued to NDC by the agreement state of California and the general license issued by other agreement states. We are required provide generally licensed device recipients with a copy of the applicable agreement state regulations. NDC makes a substantial effort to learn of proposed regulatory changes and to maintain current copies of NRC and agreement state regulations. While some agreement states maintain an effective communication program and NDC is notified of proposed and completed rule making by the agreement states, others do not.

There is not presently a mechanism by which NDC can become aware of these proposals and rule making actions. As more agreement states diverge from the NRC regulations regarding general licensees it is becoming more difficult to perform installation and service on generally licensed devices. Compliance issues such as initial registration by the general licensee, requirements for current regulations being on file with the licensee and the recent trend towards agreement states charging registration fees and or annual fees, makes it imperative for companies such as ours to have a consistent mechanism to facilitate compliance by our customer/general licensees.

While we leave the specific rule making action to the commission we strongly urge the commission to adopt such regulations that would allow for public comment to these actions taken by agreement states.

Sincerely,

~

--U--

Daniel Fishman, President FEB 2 4 19~

Acknowledged by card.. """""'.. "'"""

U.S. NUCLEAR REGULATORY COMMISSIO, OOCKETING & SERVICE SECTION OFFICE Of THE SECRET ARY I

OF THE COMMISSION Doalnent Statistics Pollfflffl Date.....:~~~... ----

Coples Rece1Ved_._ _____ _

Ad~ICo~esReproduced....::-§""" ___ _

SP.ettal Dlstrlbution_.1;.aM.,Ci.._,1:1aa."'-'.l,....._

\\

Secretary 5TATE OF WASHINGTON DEPARTMENT OF HEALTH DIVISION OF RADIATION PROTECTION DOC ETEO US C

• 94 DCC 16 A9 :25 Airdustrial Center, Bldg. 5

• P.O. Box 47827

• Olympia, Washington 985(1tJf7{1-?t

-_ o*-

~

• CRE,ARY DOC E,-Ii !~

SE:-VICE BRArCH December 7, 1994 DOCKET NUMBER pEflllON RULE.:..:PR.:;M:.....illl:::!J (ER F-R.So1 Dio)

U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch To the Commission:

This is in response to a petition to rulemaking, Docket No. PRM-150-3. The petitioner requests that NRC require Agreement States to notify NRC of all proposed and completed regulatory actions and that NRC publish such notices of Agreement States rulemaking. The state of Washington opposes this petition.

The state ofWashington has its own laws and administrative procedures concerning rulemaking. We have to follow those rules. While we have no particular concern over NRC being required to gather and publish information on Agreement State rulemaking, we cannot allow federal publication requirements to supersede our own or to inordinately delay our rulemaking process. We will certainly continue to provide information to NRC on our rulemaking process as we do now. We will, however, strenuously object ifNRC proceeds with any form of rulemaking in response to this petition which would impact the character of our rulemaking or timeframes established in state law.

We suggest it would be most appropriate for this petition to be denied and the petitioner referred to the individ.ual state programs. In our state, and probably most others, we maintain a mailing list for notifying interested parties when regulations are being considered. This allows the interested party an opportunity to participate in our rulemaking. This is an existing mechanism which should satisfy the petition's basic intent. Furthermore, since the rulemaking of concern to the petitioner is at the state level, the petitioner should develop a working relationship with the individual states. The cost FEB 2 4 1995 Acknowledged by card...... -............... 0.... ~

U.S. NUCLEAR REGUI.ATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY I OF THE COMMISSION

~

l 0ocoment Statlstiel Postmarl( Date \\a\\, '?-1 91 Copies Received~ -'--'-----

Add'I Copies Reproduced.... 3=-----

Special Oistribution_'.J\\,~:S, ::::PDry

Page Two Secretary U.S. Nuclear Regulatory Commission to the petitioner for producing a periodic form letter and postage is certainly small compared to the added bureaucracy if NRC has to develop a program to gather information from the Agreement States and publish it in the Federal Register. Since NRC is under cost recovery the petitioner will ultimately pay for this 11service 11 Thank you for the opportunity to comment.

Sincerely,

~:~

Radioactive Materials Section TCF:amw CC:

Richard Bangart, Office of State Programs Agreement States

State of Kansas Joan Finney Governor DOCKETED 1S, RC

(!)

Department of Health and Environment *94 O[ 13 P 4 :38 December 7, 1994 SECRETARY Robert C. Harder, Secretary DO I Ei h

. tBER PET,TiO J * ~ e PRM 5' CJ-3

( 51!1 FRCDJ06)

US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555 RE: PRM-150-3; PETITION BY MEASUREX CORPORATION Gentlemen:

OFFICE OF cECR ---;, RY DOCKET! 'G & SE~VICE BRANCH This is in reply to the above reference petition.

The petitioner indicates that they cannot determine when an agreement state is proposing a change to the regulations of that state which might impact on the company.

It is pointed out that at least in this state the public notice procedures are clearly outlined in state statute and regulations and publication in the Kansas Register of all proposed changes to the regulations is one of those requirements. Contacting the Kansas Secretary of State's Office at area code 913-296-3489 would have resulted in the necessary information for the petitioner to make that resource available.

The petitioner would likely find that or a similar resource available in all agreement states and the NRC Agreement criteria already assures that a regulation revision process based on state statute with opportunity for public input exists.

The names and telephone numbers of agreement state officials can be found in the Conference of Radiation Control Directory of Personnel Responsible for Radiological Health Programs.

Since all this information is already available for the cost of a small number of telephone calls and subscriptions, the petition would appear to be without basis.

~az::___

. Allen, Chief adioactive Materials & X-ray Section Bureau of Air and Radiation Radiation Control Program GWA/psw Division of Environment, Bureau of Air and Radiation Forbes Field, Building 283, Topeka, KS 66620-0001 Printed on Recycled Paper

-ft\\\\ 2 4 1995 Acknowledged by card...............................

Telephone: (913) 296-1560 FAX: (913) 296-0984 or (913) 296-1545

• NUCLFA'1 h.:

..,fir COMMISSION DOCKETlf,IG & SLriVICE SECTION OFFICE OF THE SECRET ARY OF THE COMMISSION Document Statistics Postmark Date I J-. J 4t I q, '-l Copies Acee: "'d __

-L-___

J,.dd'I Co1-C5 n~,',t,.:d....-..L-~

---=---

Special Dist ;~,:,n f2:L 7 PrJ&

-e..

---

7 j

3IVI 3M Health Physics Services December 5, 1994 3M Center, Building 220-3W-06 St. Paul. MN 55144-1000 612 736 0498 612 736 2285 Fax 65 I< T NUMBER PF, 1,*k,. J F1ULE PAM / 0-3

(~qFR1io7oo)

U.S. Nuclear Regulatory Commission Washington D. C. 20555 Attention: Docketing and Service Branch

Subject:

PRM-150-3 Gentlemen:

DOCKEfED 1;'1 US~JRC

~

• 94 DEC 12 A11 :o 2 OFFICE OF SECRET4RY DOCK ETlt,G,; SER, !Ct' BHANCH This letter is in response to the request for comments on PRM-150-3 as published in the Federal Register, Vol. 59, No. 192, Wednesday, October 5, 1994.

Until a few years ago, 3M was a radioactive source manufacturer under USNRC Byproduct Material License 22-00057-06. As such we experienced many of the same difficulties listed by Measurex Corporation as reasons for suggesting the rule change contained in PRM-150-3. Although there are a number of mechanisms by which interested parties can obtain information about proposed and actual changes to regulations in Agreement States they do not assure that interested and affected parties will, in fact, be informed. Also, there is definitely a lack of uniformity and consistency among the Agreement States in how interested parties are informed.

The rule change proposed by Measurex Corporation is one way to better assure that interested parties are informed of proposed and actual rule changes in Agreement States and to assure some uniformity and consistency among them. There are probably less complex ways to accomplish the same objective. While we support the petition submitted by Measurex Corporation, we would prefer a simpler solution for providing uniform and timely information to parties interested in Agreement State regulations. The Organization of Agreement States may be in the best position to develop such a system.

Yours;r l,;;t{d~i

/ Robert G. Wissink, Manager Health Physics Services cc: Richard A. Ratliff, Organization of Agreement States FEB 2 4 1995 Acknowledged by card.......................... ~...,

S. NUCLt.r,*

.,,, *: LuMMISSION OOCl'~E 1 :r '(, c-

• tr VICE: SECTION OFrlvL ',F fHE SECRETARY or-THE CON.. ISSION DooJIT\\e t Statistics Postmark Datt> ;1-J3=} q 'i Copie5 Rcce\\

_ / ___ _

Add'I r,op*,,:. F:~

1 (?d -

-=-3 ___ _

Spe~ 1:!I J*,::, ltJ,!C,:-' 't.5-

, Pnfl,

7)

~

Georgia Department of Natural Resources 205 Butler Street, S.E., East Floyd Tower, Atlanta, Georgia 30334 OOC.<E r UMBER PETITI01 RULE PRM / S {} -]

(sq P R,0106)

U. S. Nuclear Regulatory Commission Attention: Docketing and Service Branch Washington, D.C. 20555 Harold F. Reheis, Director

. T Joe D. Tanner, Commissioner (f)

Environmental Protection Division

J December 1, 1994 DOCKETED USNRC

• 94 DEC -9 A 9 :34 OFFICE OF SECRETARY DOCKETI NG &. SERVICE BRANCH RE: Federal RegisterNol. 59, No. 192/October 5, 1994/Proposed Rules Gentlemen:

I am responding to PRM-150-3 the petition for rule making published in the referenced Federal Register Notice.

We do not support the petitioner's request and ask NRC to deny the request. Georgia, like other states, has Administrative requirements for rule making. These requirements are time consuming enough without adding additional time consuming requirements onto the Agreement States. In fact, attempting to comply with requirements as the petitioner requests could, and very probably would, render the rule making process for the Radioactive Materials Program inconsistent with our own Administrative requirements. This could leave the Program open for legal challenge to the validity of promulgated rules.

The petitioner's request, if granted by NRC, would establish a rule making requirement for Agreement States that is inconsistent with requirements of other federal agencies.

For example, OSHA and EPA do not require nor are they required to publish in the Federal Register occupational safety laws or environmental laws respectively, promulgated by the various States.

Measurex and other Corporations do not need another version of "Federal Corporate Welfare" to remain competitive in the market place. It is incumbent upon them to keep abreast of the requirements in the various states in which they wish to do business. Just because it may be inconvenient for them does not make it impossible for them to engage in interstate commerce.

TEH:klc I :\\wp51 \\nrc\\letters\\secretar Sincerely,

~nf/JM Thomas E. Hill, Manager Radioactive Materials Program FEB 2 4 1995 Acknowledged by card.... :."...................-........,

". ", ",.:;:Vt~

,)~-. /,Cc ~;H~ 1 iCN

..-lf:: SE.CF,rT ARY Do,r;,e ' ~tatistics Postma~ D t Co?ies, c, *

,:: 'l Co" r., 1

~

I I

I I

I I

CABINET FOR HUMAN RESOURCES COMMONWEAL TH OF KENTUCKY FRANKFORT 40621-0001 DOCKETED USNRC

• 94 DEC - 8 A10 :11 DEPARTMENT FOR HEAL TH SERVICES November 29, 1994 SECRETARY OFF!f.E OF SECRETARY DOCKETING t. SERV1cr-9RANCH DOCKETING AND SERVICE BRANCH DOC'G:T i ;:.JMSER US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555

• Trr, J nuL 1: PRM L so - 3*

Dear Sir:

This letter provides comments on the petition for rulemaking Docket No. PRM-150-3, filed by Measurex Corp. as provided to Agreement States in letter dated October 12, 1994 (SP-94-146).

I oppose the petition for the following reasons:

1.

Our state, as does probably other states, has an Administrative Register in which proposed or amended regulations are published.

This is available to manufacturers or other interested individuals by subscription.

Let manufacturers subscribe to each states' document for notifying members of the public about regulatory changes if they want to be kept informed.

2

• The petitioner says their costs would be increased based on Oregon'~ proposed regulations to eliminate general licenses authorizing installations, demonstrations, etc.

However, the regulation Measurex is proposing would be an increased cost to Agreement States.

This would in turn lead to an increase in licensing fees in order to recover the additional costs.

Could this not discourage some potential licensees from purchasing devices such as Measurex manufacturers?

3.

Measurex's proposed amendment requires Agreement States to hold informal hearings and/or afford opportunities to participate in promulgation of regulations.

States already have formats for public participation mandated by an individual states' legislative body.

It is not for NRC to interfere in this process which is the same process used to promulgate all state regulations whether pertaining to radioactive materials or not.

4.

Other companies selling products interstate, not involving radioactive materials, must also be knowledgeable of that particular states' requirements.

An example, would be studded snow tires, fireworks, etc. (not all states allow them).

Therefore, Measurex does not have any undue hardship imposed on their company that is any different from what other companies deal with.

'fEB 2 4 1995 Acknowledged by card..........................,.... o "An Equal Opportunity Employer M/F/H"

~- N'uCLE),; '.".

_.,_,,,YOriY COMMfSStOi*

DOC:<t::W~G & SERVICE SECTION OFF:CE OF 1HE: SECRET ARY OF THE COMMISSION Document Statistics

,9pies r:e.. cived ___.1.------

Ac!d :-Co;:):es Rerroouced _Jie:..------

~1,c* ~, Dist..bJfon~n=:t:.=!J=5'-l)- f}

.__,,,QLJ~'-"-' - -

_ L -e.

a.,

Secretary November 29, 1994 Page Two Overall, I think manufacturing companies' efforts in keeping up with regulatory changes are simply a cost of doing business across the nation.

Thank you for the opportunity to provide comments.

VDJ/tg Sincerely,

-~ _;£ 62-. w--

Vicki D. Jeffs, Supervisor Radioactive Materials Section Radiation Control Branch

D./,:..: T ~1U'.'vbiH PErmoi* Ru* t; PR~ lso-3 (5q FR S0106)

State of Louisianjocr~Tf US R, Department of Environmental Quality Edwin W. Edwards Governor William A. Kucharski November 14, 1994 Secretary U. S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch OFFiCE OF SECRETARY DOCKETING,l :ER :1r~[

BRANC'1 Re: Petition for Rule-making, Measurex Corporation (SP-94-146)

Dear Sir:

Secretary The State of Louisiana, under its public records laws, is required to make a copy ofits rules and proposed rules available upon request. The petitioner needs only to subscribe to the Louisiana Register, in which all proposed rules and promulgated rules are formally noticed.

If the petition should become r("gulation, it would impose additional requirements that would become burdensome to both the Agreement States and the NRC without commensurate benefit to either. This is a way for business to require government to do for a small group what they could and should do for themselves. Also, additional requirements to publish these materials would be redundant and needlessly expend tax dollars that could provide more benefit elsewhere in the field of radiation protection.

Thank you for the opportunity to provide these comments.

WHS/MEH/whs c:

NRC Office of State Programs Association of Agreement States Conference of Radiation Control Program Directors, Inc.

Very truly yours,

-1(~,-<.4/A-William H. Spell, ~strator Radiation Protection Division OFF,CE OF AIR QUALI TY RAD iATION PROTECTION DIVISION P.O. BOX 82135 BATON ROUGE LOUISIANA 70884-2135 0

TELEPHONE (504) 765-0160 FAX (504) 765-0220 ffB 2 4 1995 AN EQUAL OPPORTUNITY EMPLOYER recycle::i paper Acknowledged by card..............................

"'"'1.*

• ,.,...

  ,.:1/41:vilS:::>iON KET.~ '..3 & <-E ;ViCE SECTION OFFICE OF THE SECRET ARY OF THE COM ISSION Docume t Statistics Postmarl( Date I I I 1

/ &/ L-/

Co~esRcceivcd ___ ~I.--___ _

Add'I Coples Reprocucf'd -'-------

Special Distribution r2J;):?5.t POr2.,

_Le-5'.?t..r

(503) 731-4014 FAX (503) 731-4081 TDD-Nonvoice (503) 732-4031 DOCKET NUMBER 3

PETITION RULE PRM J f_ (J _:-

OOCt<.ETED US RC November 4, 1994 (S 1Ff?.501() 6)

• 94 ov _8 P 4 :z WEPARTMENT oF HUMAN Secretary OFFICL uf,::._( q[ li~RlyESOURCES C KE nw: " <'f R

• 1 U.S. Nuclear Regulatory Commission Washington D.C. 20555 Attention: Docketing and Service Branch Comments on Docket No. PRM-150-3 Nuclear Regulatory Commission - 10 CPR PARTS 2 AND 150 Federal Register/ Vol. 59. No. 192 / Wednesday, October 5, 1994 BRANCH The Oregon Health Division is strongly opposed to the petitioners request for proposed rules to require the Nuclear Regulatory Commission (NRC) to require Agreement States to notify the NRC of all proposed and completed regulatory actions.

The Health Division also strongly opposes the petitioners request to require the NRC to publish (in the Federal Register) Agreement State notices of proposed and completed rulemaking.

Oregon, as an Agreement State, already routinely notifies the NRC of all proposed and completed regulatory actions. This is done at the Headquarters and/or Regional levels.

The State also seeks comments from NRC prior to promulgation, therefore the NRC is aware of all revisions. The proposed rule by the petitioner is not needed.

The proposed amendment for the NRC to be required to publish Agreement State notices of proposed and completed rulemaking in the Federal Register is likewise not needed.

All interested parties to proposed rule changes are properly notified. The petitioner used Oregon as an example to illustrate that how the current system is inadequate. However, the petitioner did not mention how the misunderstanding was successfully resolved and how steps were taken to prevent similar problems in the future. Oregon not only gave the petitioner all the information requested, but the comment period was purposefully extended to allow the petitioner time to formulate their comments and get them submitted to the Public Hearings Officer. The petitioners comments were received and the final rules reflected their desires. The computerized mailing list has been modified and the petitioner will receive routine mailings of all notices.

The two illustrations cited by the petitioner do not warrant amendments as proposed in Docket No. PRM-150-3 Sincerely~~

R~Paris, Manager Radiation Protection Services c: Jack Horner, NRC tm/V4/Sec-Nrc.ltr*l l/4/94-2: 17 HEALTH DIVISION Barbara Roberts Governor 800 NE Oregon Street # 21 Portland, OR 97232-2162 (503) 731-4030 Emergency (503) 252-7978 TDD Emergency fE8 2 t 219§r-1

-9zi Acknowledged by card.........................,,.,.... ~

l).S. h.1 00\\..

Of

.., ! *-,'J JI.:Ti-'f1'f o~-= 1? ~L c<jl ;r'-~1SStON

OO'"'KET NUMBER J

PL-:-ITIO RULE PRM J~O,; jl II II U°lrfl~o106J,.,1,1, October 24, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch

Subject:

Comments on Docket No. PRM-150-3

Dear Sirs:

• 94 DOCKETED USNRC NOV -4 P3 :37

~ angart, SP cys :Taylor Milhoan Thompson Blaha Norry, ADM

"° 0 <

I C)

N U>

-0

-0

x

.i:-..

U1 A petition for rulemaking was filed by Measurex Corporation and published in the Federal Register on Wednesday, October 5, 1994, page 50706. This is identified as Docket No. PRM-150-3 and relates to desired changes in 1 O CFR Parts 2 and 150.

We strongly endorse this petition for rulemaking, as presented in the Federal Register, to:

(1) require Agreement States to notify the NRC of all proposed and completed regulatory actions, and (2) require the NRC to publish Agreement State notices of proposed and completed rulemaking.

We are a major manufacturer, distributor, and supplier of services for industrial process measurement and control systems used by NRC and Agreement State licensees throughout the USA. We continually experience the problems identified by this petitioner. The proposed rulemaking would help identify potential changes in Agreement State regulations that affect us and our customers in those agreement states. Such notification would hopefully alert the NRC to possible rule inconsistencies and non-compatibility problems before changes are finalized.

It would provide notification for all licensees to facilitate the opportunity to participate in the rulemaking process by working directly with the responsible Agreement State authorities. And, it would improve awareness, communications and understanding of new Agreement State regulations. Implementing the rulemaking in this petition would have a positive benefit for all involved.

Again, we strongly endorse this petition for rulemaking.

Sincerely,

(!)

z:.e

• FEB 2 4 1995 Acknowledged by card..............................,~

Nucleonics and Radiological Operations 650 Ackerman Road P O Box 02650 Columbus. Ohio 43202-1502 ABB Industrial Systems Inc.

Telephone 614 261-2000 Telex:

246675 NRC10244.DOC Telefax 614 261-2172

'1. ~?

r c, ~.. /..

.,:)

DOCKET NUMBER PETITION RULE PRM t-5

-3 (SCf F'f?507tJ6.

NUCLEAR REGULATORY COMMISSION DOCKETED

[

~ ;qi, 01-P]

• 94 OCT -3 A10 :51 10 CFR Parts 2 and 150 (Docket No. PRM-150-3 J OFf ICF. Q,- '

ooc:'~Ti 1*1 Measurex Corporation, Receipt of a Petition for Rulemaking AGENCY:

Nuclear Regulatory Commission.

ACTION:

Petition for rulemaking; Notice of receipt.

SUMMARY

The Nuclear Regulatory Commission (NRC) has received and requests public comment on a petition for rulemaking filed by the Measurex Corporation.

The petition has been docketed by the Col".lmission and has r~en assigned Docket No. PRM-150-3.

The petitioner requests that the NRC amend its regulations governing Agreement State regulation of byproduct material to require Agreement States to notify the NRC of all proposed and completed regulatory actions.

The petitioner also requests that the NRC amend its regulations governing rulemaking to require the NRC to publish Agreement State notices of proposed and completed rulemaking.

The petitioner believes that these amendments would alert NRC and Agreement State licensees of applicable Agreement State requirements and permit them to more fully participate in the rulemaking process.

/ 'J___ l I '1 } o/ '-/

DATE:

Submit comments by (75 days following publication in the Federal Register).

Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this 'date.

p~. 101sIc,'-1

ADDRESSES:

Submit comments to:

Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

Attention:

Docketing and Service Branch.

Deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm on Federal workdays.

For a copy of the petition, write:

Rules Review Section, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

FOR FURTHER INFORMATION CONTACT:

Michael T. Lesar, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

Telephone:

301-415-7163 or Toll Free:

800-368-5642.

SUPPLEMENTARY INFORMATION:

Background

The Nuclear Regulatory Commission (NRC) received a petition for rulemaking dated April 7, 1994, submitted by the Measurex Corporation.

The petition was docketed as PRM-150-3 on April 12, 1994.

The petitioner requests that the NRC amend its regulations in 10 CFR Part 150 that govern Agreement State regulation of byproduct material.

Specifically, the petitioner is seeking an amendment to 10 CFR 150.31 that will require Agreement States to notify the NRC of proposed and completed changes to that State's regulations.

The petitioner is also seeking an amendment to 10 CFR Part 2 that will require the NRC to publish Agreement state notices of proposed and completed rulemaking in the Federal Register.

2

The petitioner notes that current NRC requirements contained in 10 CFR 2.804 through 10 CFR 2.807 establish a procedure for the publication of proposed changes, participation by interested persons, and notification of changes, and believes that a less detailed set of rulemaking and notification procedures is specified for Agreement States in 10 CFR 150.31.

The petitioner I

claims that the current rulemaking and notification procedure contained in 10 CFR 150.31 fails to provide a mechanism for persons located outside of any particular Agreement State to learn about proposed changes in that State's regulations.

The petitioner believes that the legislative intent of lu CFR 150.31 is to provide a mechanism for interested persons to participate in the rulemaking process.

However, the petitioner claims that because there is no current notification procedure required for Agreement States, the petitioner and other persons do not have ample opportunity to participate in discussion of proposed rules.

The petitioner states that under both its specific license for device distribution issued by the Agreement State of California and the general license issued by other Agreement States, it is required to provide generally licensed device recipients with a copy of the applicable Agreement State regulations.

The petitioner also indicates that although it makes a substantial effort to learn of proposed regulatory changes and to maintain current copies of NRC and Agreement State regulations, it is not always notified of actual changes that may directly affect it and its customers in Agreement States.

The 3

petitioner believes that the proposed amendments to 10 CFR Parts 2 and 150 would alert NRC and Agreement state licensees to all relevant Agreement State requirements and permit them to more fully participate in the rulemaking process.

The NRC is soliciting public comment on the petition for rulemaking submitted by Measurex Corporation that requests the r

changes to the regulations in 10 CFR Parts 2 and 150 as discussed below.

The Petitioner The petitioner is a manufacturer, distributor, and supplier of service for process control sensors use'~ by NRC licensees throughout the United States.

The petitioner states that it and its customers are directly affected by regulations adopted by the NRC and Agreement States.

The petitioner also states that both its specific license for device distribution issued by California, an Agreement State, and other Agreement State licenses require it to provide generally licensed recipients &

copy of the applicable Agreement State regulations.

For these reasons, the petitioner claims that it makes a considerable effort to learn of proposed regulatory changes and to maintain current copies of NRC and Agreement state regulations.

The petitioner indicates that it is submitting this petition for rulemaking to amend 10 CFR Parts 2 and 150 because it believes that the current regulations completely fail to provide a mechanism Iur persons located outside any particular Agreement 4

State to learn about proposed and completed changes to that State's regulations.

The petitioner believes that because there is no adequate mechanism to keep NRC licensees aware of current Agreement State regulations, it is unable to fully participate in discussion of proposed rules and is often unaware of actual regulatory changes that directly affect it and its customers in Agreement States.

Discussion of the Petition The petitioner has submitted this petition for rulemaking because it believes that it is adversely affected L1 th~ current regulations that do not provide an adequate mechanism for NRC licensees to learn about proposed and adopted changes in applicable Agreement State regulations.

The petitioner states that although the current NRC regulations in 10 CFR 2.804 through 2.807 establish a procedure for the notification and publication of regulatory changes and participation by interested persons, it believes that a less d~cailed set of rulemaking and notification procedures is specified for Agreement States in 10 CFR 150.31.

The petitioner's primary concern is that it and other NRC licensees are not always notified of proposed and completed changes in Agreement State regulations that can directly affect themselves and their customers in Agreement States.

The petitioner is also concerned that because it is often not aware of Agreement State regulatory actions, it does not have the opportunity to fully participate i~ the rulemakic~ process ~sis 5

intended by NRC regulations.

As part of its petition for rulemaking, the petitioner has included copies of various correspondence with Agreement state radiation control boards and the NRC, and cites specific cases in the Agreement States of Oregon and Texas that it believes will illustrate that the current rules are unduly burdensome, deficient, and in need of I

strengthening.

For example, in Oregon, regulatory changes are proposed that would eliminate the general license authorizing the petitioner to install, transfer, demonstrate, or provide service and would require the petitioner to obtain a specific license from Oregon in order to conduct business.

If these proposed regulations are adopted, the petitioner states that it will be able to ship sensors to a customer in Oregon only after confirming that the customer has an appropriate specific license.

The petitioner is concerned not only that the proposed regulations would impose additional burdens and costs c~1 it and its customers in conducting business in Oregon, but also that it was not provided ample opportunity to comment on the proposed rules or to participate in the rulemaking process.

Although the petitioner attempted to learn about any proposed or adopted regulatory changes by writing to the Oregon Radiation Control Section on several occasions between June 1991 and January 1994, it did not receive a response.

The lack of response led the petitioner to believe that Oregon had not modified its 1987 radiological control regulations even though the current version of the Oregon Administrative Rules for the 6

Control of Radiation was adopted in 1991.

The petitioner stated that it only became a~are of the changes in Oregon's notification requirements in February 1994 when informally contacted by an out-of-state health physics colleague.

The petitioner also described a case in which it did not learn of regulatory modifications adopted by the Agreement State

(

of Texas in 1993 until after the rules became effective.

These regulations govern distribution and service involving generally licensed devices.

The petitioner claims that the new requirements are costly and administratively burdensome and again exp1essed the concern th~t i~ was not able ~u participate in discussions of proposed rules that affect it and its customers before the rules became effective.

The petitioner acknowledges that although some State's radiation control agencies are conscientious in notifying out-of-state distributors or service groups about proposed and completed regulatory changes, many do not make such an effort.

For these reasons, the petitioner indicates that it and other firms have no way of knowing when copies of a State's regulations are no longer valid and, consequently, have no opportunity to participate in the rulemaking process.

The petitioner stated that its efforts to gain information regarding Agreement State regulatory changes are costly, time-consuming, and often ineffective.

To alleviate this situation, the petitioner proposes that 10 CFR 150.31 be amended to require Agreement States to notify the NRC of any proposed regulatory actions and that 10 CFR Part 2 7

be amended to require the NRC to publish the Agreement State notices of proposed regulatory actions in the Federal Register.

The NRC staff would like to inform the readers that 10 CFR 150.31 applies only to lle(2) byproduct material (tailings and other wastes generated from the milling of ores primarily for their source material content) and reflects statutory requirements in the Uranium Mill Tailings Radiation Control Act of 1978, as amended.

Similar requirements could be developed to apply to other byproduct material.

In order to avoid confusion with the requirements for lle(2) byproduct material, the proper location for these new requirements would need to be considered in the development of any new section in Part 150.

The Petitioner's Proposed Amendment The petitioner requests that 10 CFR Parts 150 and 2 be amended to overcome the problems the petitioner has itemized and recommends the following revisions to the regulations:

1.

The petitioner proposes that§ 150.31 be amended by redesignating existing paragraph (c) as paragraph (d),

redesignating existing paragraph (d) as paragraph (e), and adding a new paragraph (c) to read as follows:

S 150.31 Requirements for Agreement State regulation of byproduct material.

(c)

After [date], in the licensing and regulation of byproduct material, as defined in§ 150.J(c) (2) of this part, or of any 8

activity which results in the production of such byproduct material, an Agreement State shall require compliance with procedures which:

(1)

Include the requirements of paragraph (b) of this section, and (2)

In the case of rulemaking also include:

(i)

Except as provided by paragraph (c) (2) (iv) of this section, when it proposes to adopt, amend, or repeal a regulation, shall submit notice of the proposed change to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Chief, Docketing and Service Bra~ch.

(ii)

The notice will include:

(A)

Either the terms or substance of the proposed rule, or a specification of the subjects and issues involved; (B)

The manner, time, and place within which interested members of the public may comment, and a statement of where and when copies of such comments may be examined.

(C)

The authority under which the regulation is proposed; and (D)

The time, place, and nature of the public hearing, if any.

(iii)

The notice required in paragraph (c) (2) (i) of this section will be made not less than [number to be determined) days prior to the time fixed for hearing, if any, unless the Agreement State for good cause stated in the notice provides otherwise.

(iv)

The notice and comment provisions contained in paragraph (c) (2) (i), (ii), and (iii) of this section will not be required to be applied--

9

(A)

To interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice; or (B)

When the Agreemer.~ state for good cause finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest, and are not required by statute.

This finding, and the reasons therefor, will be incorporated into any

(

rule issued without notice and comment for good cause.

(v)

The Agreement State shall provide for a 30-day post-promulgation comment period for--

(A)

Any rule adopted without notice and comment under the good cause exception in paragraph (c) (2) (iv) (B) of this section where the basis is that notice and comment is "impracticable" or "contrary to the public interest;" or (B)

Any interpretive rule, or general statement of policy adopted without notice and comment under paragraph (c) (2) (iv) (A) of this section, except for those cases for which the Agreement State finds that such proce~ures would serve no public interest, or would be so burdensume as to outweigh any foreseeable gain.

(vi)

For any post-promulgation comments received under paragraph (c) (2) (v) of this section, the Agreement State shall submit a statement to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:

Chief, Docketing and Service Branch.

This statement shall contain an evaluation of the significant comments and any revisions of the rule or policy statement made as a result of the comments and their evaluation.

10

(vii)

The Agreement State will afford interested persons an opportunity to participate through the submission of statements, information, opinions, and arguments in the manner stated in the notice.

The Agreement State may grant additional reasonable opportunity for the submission of comments.

(viii)

The Agreement State may hold informal hearings at which interested persons may be heard, adopting procedures which in its judgment will best serve the purpose of the hearing.

(ix)

When it has adopted, amended, or repealed a regulation, the Agreement State will submit notice of the action to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:

Chief, Docketing and Service Branch.

(x)

The notice of adoption, amendment, or repeal of a regulation provided by an Agreement State to fulfill the requirements of paragraph (c) (2) (ix) of this section will specify the effective date and include a concise general statem,~nt oft~~

basis and purpose of the change.

S1~ch notice will be made not less than [number of days to be determined] days prior to the effective date, unless the Agreement state directs otherwise on good cause found and included in the notice of rulemaking provided in fulfillment of paragraph (c) (2) (x) of this section.

2.

The petitioner proposes that 10 CFR Part 2 be amended to add a S 2.810 to read as follows:

§ 2.810 Notice of proposed rulemaking by Agreement states.

11

(a)

When the Commission, in fulfillment of the requirements of S 150.Jl(c) (2) (i) of this chapter, receives Agreement State notice of a proposal to adopt, amend, or repeal a regulation, it will cause the notice to be published in the Federal Register.

The publication of this notice will be made not less than fifteen (15) days prior to the time fixed for hearing, if any.

(b)

When the Commission, in fulfillment of the requirements of S 150.Jl(c) (2) (vi) of this chapter, receives an Agreement State statement of post-promulgation comments, it will cause the statement to be published in the Federal Register.

\\~I When the Commission, in fulfillment of the requirements of S 150.Jl(c) (2) (ix) of this chapter, receives an Agreement State notice of the adoption, amendment, or repeal of regulations, it will cause the notice, including the effective date, to be published in the Federal Register.

Dated at Rockville, Maryland, this _11 ;I, day of~v, 1994.

12

measurex C ORPORATION OOCKE.T NUMBER ~

L 3 PET\\T\\ON RULE PRU a-.*

7 April 1994 Secretary (t;Cf FR so1ob)

U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention:

Dear Director:

Chief, Docketing and Service Branch Petition for Rulemaking

/ I :. l I,

As authorized by Section 2.802, Title 10 of the Code of Federal Regulations (10 CFR), Measurex Corporation petitions the Nuclear Regulatory Commission (NRC) to amend its regulations concerning Agreement State regulation of byproduct material. The details required by 10 CFR 2.802 are given in the remainder of this letter.

Identity of regulations requested for amendment: 10 CFR 150.31; 10 CFR 2.

Statement of petitioner's grounds for interest in the requested action: As a manufacturer, distributor, and supplier of service for process control sensors used by General Licensees in nearly every state in the U.S., Measurex Corporation and our customers are directly affected by the regulations adopted by Agreement States and the NRC.

In addition, both our Specific License for device distribution (issued by the Agreement State of California) and individual Agreement States require us to furnish Generally Licensed device recipients with a copy of the applicable Agreement State regulations. For these reasons, we make a considerable effort to learn of proposed regulatory changes and to maintain up-to-date copies of NRC and Agreement State regulations.

In the case of NRC regulations, Sections 2.804 through 2.807 of Title 10 of the Code of Federal Regulations (10 CFR) establish a procedure for the publication of proposed changes, participation by interested persons, and notification of changes.

For Agreement States, a less detailed set of rulemaking and notification procedures is specified in 10 CFR 150.31.

In our experience, the 10 CFR 150.31 rulemaking and notification procedure completely fails to provide a mechanism for persons located outside any particular Agreement State to learn about proposed changes in that state's regulations.

In the absence of such a mechanism, Measurex and others are excluded from 10 CFR 150.31 's clearly-intended opportunity to participate in discussion of the proposed rules.

And we are not necessarily notified of actual changes that may directly affect us and/or our customers in Agreement States.

MEASUREX CORPORATION ONE RESULTS WAY CUPERTINO, CALIFORNIA 95014-5991 (408) 255-1500

DOCKETED USNRC

• 94 APR 12 P 3 :46 OFFICE OF SECRETARY DOCKETING & SERVICE BRANCH

DOCKEiED USNRC "94 APR 12 P3 :46 OFFICE OF SECRETARY DOCKETING & SEP.VICE BRANCH

measurex Specific cases where the current rule is unduly burdensome, deficient, and needs to be strengthened: Based on the problems described below, Measurex maintains that the current rule is deficient and that it needs to be strengthened.

Problems in notification of proposed changes in Agreement State regulations:

There may be many Agreement States where regulatory modifications are in process or have been completed within past years.

However, since such information is not readily available to Measurex, this letter will describe only two cases that involve the Agreement States of Oregon and Texas.

OREGON:

TEXAS: (letter dated 21 March 1994 from Measurex to Richard Bangart of the NRC Office of State Programs) describes one portion of the regulatory changes proposed by Oregon and why it is of serious concern to Measurex.

Measurex does not know when the changes were officially proposed or whether Oregon followed its own Administrative Rules for the Control of Radiation (i.e. Section 333-102-345[2])

regarding publicizing the proposals. But, although Measurex sends the Oregon Radiation Control Section a report once each calendar quarter to report shipments of Generally Licensed devices to customers in Oregon, and although the proposed changes would directly and significantly affect both Measurex and our customers, we were not notified by the Oregon Radiation Control Section. We were fortunate to learn of the proposed modifications on 22 February 1994 when informally contacted by an out-of-state health physics colleague.

In the case of regulatory modifications adopted by the Texas Bureau of Radiation Control in 1993, Measurex did not learn of the planned modifications until after their 1 September 1993 effective date.

(Note Attachment 2; fax dated 7 October 1993 from Measurex to the Texas Bureau of Radiation Control.)

Once again the regulatory modification is a significant one that directly affects how Measurex conducts its business (e.g. ; letter dated 21 February 1994 from Measurex to Ralph Heyer). And once again, the involved agency clearly knew that the change would affect out-of-state firms, since they did notify us in writing about at least some of the changes after they had been adopted (Attachment 4; letter dated 7 September 1993).

However, at that point there was obviously no opportunity to participate in the rulemaking.

Problems in notification of adopted changes in Agreement State regulations:

While there may be a number of states radiation control agencies that are conscientious in notifying out-of-state distributors or service groups when they either propose to change or have changed their regulations, many do not make

measurex such an effort.

Because this is the case, Measurex and other firms have no way of knowing when copies of the state regulations have gone out of date.

Attachments 5 and 6 (regulations worksheet; letter from Measurex to the Oregon Radiation Control Section) show some of what Measurex has done in the past to attempt to maintain current copies of the state regulations that we use as references and supply to customers.

Unfortunately, not only are these routine efforts to gain information time-consuming, it is our experience that they also sometimes ineffectual. Despite at least three written requests between 1991 and 1994 (Attachments 6 - 8; letters from Measurex to Oregon Radiation Control Section), Measurex never received a response. And, we incorrectly believed that the absence of a response meant that Oregon had not modified its 1987 regulations. However, in February 1994 we learned that the current version of the Oregon Administrative Rules for the Control of Radiation were adopted in 1991.

Proposed solution: Measurex proposes that the NRC amend:

o 10 CFR 150.31 to (in most cases) require Agreement States to notify the NRC of both proposed and completed action to adopt, amend, or repeal regulations.

o 10 CFR 2 to have the NRC cause the Agreement State notices of proposed rulemaking and completed rulemaking to be published in the Federal Register.

Wording for the amended regulations is proposed in Attachments 9 and 10.

Your response to this petition for rulemaking will be appreciated.

Sincerely, Elsa Nimmo Radiation Safety Officer CC:

Edgar Bailey - CA OHS Richard Bangart - U.S. NRC David Berrick - Subcommittee on Environment, Energy, and Natural Resources Jack Hornor - U.S. NRC Bob McAdams - 5101 Charles Van Orden - 2234 Radiation Safety Committee

measurex CORPORATION 21 March 1994 Mr. Richard Bangart Office of State Programs Mail Stop 3D23 U.S. Nuclear Regulatory Commission Washington D.C. 20555

Subject:

Proposed Revisions to the Oregon Administrative Rules for the Control of Radiation: Licenses for Certain Measuring, Gauging, or Controlling Devices

Dear Mr. Bangart:

As we discussed in our phone call on 11 March and as described in a 3 March letter from Measurex to Ray* Paris, the Oregon Radiation Control Section (the Agency) has proposed some regulatory changes. A copy of the proposed modification that is of particular concern to Measurex, Section 333-102-115, is attached (compare to 10 CFR 31.5).

For the State of Oregon, the proposed changes would:

o Eliminate the General License that authorizes Measurex to install, transfer, demonstrate, or provide service; require Measurex to get a Specific License from Oregon.

0 Note: Measurex and other manufacturers presently provide service in Oregon under the General License in Section 333-102-340(1)(b);

standard "reciprocity" as granted in Section 333-102-340(1)(a) is not practical due to the three-day notice provision and the 180 day/year limit.

Eliminate General Licenses for existing and future Measurex customers and require Specific Licenses; require Measurex to ship sensors only after confirming that the customer has an appropriate Specific License.

In the 3 March letter, Measurex petitioned the Agency to delay the close of the comment period on the proposed regulations until appropriate out-of-state firms had been officially notified and given adequate time to prepare a response. In a 17 March phone call, Ray Paris, Program Director, stated that he could not insure that the comment period (scheduled to end 22 March) would be extended. He promised to review the records of out-of-state firms that had shipped Generally Licensed devices to Oregon and that the Agency would follow up with phone calls to any such firms that might be unaware of the proposed regulations.

Eliminating the General Licenses used by Measurex, its competitors, and our customers in Oregon is not a trivial matter.

10 CFR 150.31 (b )(3)(i-ii) requires Agreement States to provide an opportunity for written comments or other MEASUREX CORPORATION ONE RESULTS WAY CUPERTINO. CALIFORNIA 95014-5991 (408) 255-1500

measurex C

O RPORATION participation before taking action to modify licenses or rules.

While Measurex sincerely appreciates Ray Paris' consistent willingness to discuss the issues and his offer to take further action, we submit that notification by phone three working-days before the close of the comment period does not constitute adequate opportunity for participation by those who would be directly affected by this license loss.

Furthermore, it apparently would not have been easy for an out-of-state firm to learn of the planned changes by other normal means.

As described in the 3 March letter to Ray Paris, the Agency did not respond on several occasions between June 1991 and January 1994 when Measurex specifically requested information on the latest regulations. Accordingly, Measurex requests that the NRC Office of State Programs withhold approval of Oregon's proposed modification to Section 333-102-115.

We are also aware that the entire issue of "compatibility" between the NRC and Agreement State regulations is presently under serious debate. Given that the manufacture, distribution, and servicing of Generally Licensed devices involves manufacturers, service organizations, and customers in nearly every state, compatibility questions are especially relevant to regulations that affect General Licensees. While compatibility discussions continue, approving one state's unique definition of Generally Licensed devices would be particularly !11-advised.

For the reasons described in this letter, Measurex requests the Office of State Programs to withhold approval of Oregon's and other Agreement States' requests to modify regulations that involve Generally Licensed devices and related service.

Sincerely, MEASUREX CORPORATION Elsa Nimmo Radiation Safety Officer CC:

Edger Bailey - CA OHS Jim Creek - WA Jack Hornor, U.S. NRC Bob McAdams - 5101 Ray Paris - OR RCS Charles Van Orden - 2234 Radiation Safety Committee Attachments:

MEASUREX CORPORATION ONE RESULTS WAY CUPERTINO, CALIFORNIA 95014-5991 (408) 255-1500 RADIATION SAFETY DEPARTMENT MEASUREX CORPORATION, One Results Way, Cupertino, CA 95014 U.S.A.

Phone: (408) 725-3155 Date: 7 October 1993 To:

Mr. Floyd R. Hamiter, Chief CC:

Industrial Program, Division of Licensing, Registration, and Standards Bureau of Radiation Control Austin, TX Mike Goss Bob McAdams John Powell Charles Van Orden Radiation Safety Committee From: Elsa Nimmo - 4262 Fax No.:

(408) 253-7658, or (408} 864-7570

Subject:

Letters Dated 7 and 10 September 1993 Regarding New Requirements for Distribution and Service Involving Generally Licensed Devices

Dear Mr. Hamiter:

From your letter on General License Distribution (7 September) and a letter from Wesley Dunn on reciprocity (10 September 1993),

we note that the Texas Department of Health (the "Agency") has ado~ted some new requirements, effective 1 September 1993.

From the information in the letters, it is clear that these new requirements will affect Measurex, as an out-of-state company that distributes devices to General Licensees in Texas and as a company that also provides on-going service to those devices.

We also understand that some of the changes will affect our customers within Texas.

Despite prompt requests, Measurex was not able to obtain copies of the modified regulations from the Agency until 5 October 1993.

We note that under the modified regulations, we are required to file a "Notice of Intent to Work in Texas Under Reciprocity" to cover Measurex employees installing, transferring, testing, maintaining, and repairing sensors manufactured by Measurex and possessed by a firm in Texas under provisions of a General License or a Specific License.

Measurex will file a "Notice of Intent to Work in Texas Under Reciprocity" as soon as possible, and no later than 1 November 1993.

In the interim, we request that the Agency not cite Measurex for non-compliance with the new requirements.

Sincerely, Elsa Nimmo

measurex CORPORATION 21 February 1994 Mr. Ralph S. Heyer Division of Licensing, Registration, and Standards Bureau of Radiation Control 1100 West 49th Street Austin, TX 78756-3189

Subject:

Your Letter re. Reciprocity for California License No. 1663

Dear Mr. Heyer:

We have received your letter in response to Measurex's request for reciprocal recognition for California License No. 1663. In that letter, Measurex is granted a partial exemption from the requirement to notify the Bureau of Radiation Control ("the Bureau") in advance of activities involving Generally Licensed industrial thickness gauges. We appreciated the Bureau's willingness to consider our request for an alternate way of responding to the new requirements. However, as the remaining requirements are worded, Measurex is still faced with costly and administratively burdensome over-notification for activities that have no potential to expose anyone to radiation risks.

We request an opportunity to meet with you at your convenience. At this meeting we propose to:

o Describe the sensor systems and the types of service operations that involve Measurex employees at sites within the State of Texas o

Explain why the wording of the remaining requirements still poses major problems for Measurex 0

Suggest alternatives that would supply useful information without being an excessive burden to either the Bureau or Measurex.

Please contact me at 408 725-3127.

Sincerely, Elsa Nimmo Radiation Safety Officer CC:

Mike Goss - AL Bob McAdams - 5101 Charles Van Orden - 2234 MEASUREX CORPORATION ONE RESULTS WAY CUPERTINO. CALIFORNIA 95014-5991 f4081 255-1500 Texas Department of Health David R. Smith, M.D.

Commissioner September 7, 1993 Elsa Nimmo Measurex C<m,oration One Results Way Cupertino, California 95014 1100 West 49th Street Robert A. MacLean,M.D.

Austin, Texas 78756-3189 Deputy Commissioner (512) 458-7111 Radiation Control (512) 834-6688 Re:

General License Distribution The Agency has recently revised the Texas Regulations for Control of RadiaMon (TRCR), effective September I, 199_31 to include the addition of a new Part 40, "Exem12tions, Gener Licenses, and General License Aclcnowleogements", and revisions to Part 41, "Licensing of ~adioactive Material."

Under the new Part 40i the Agency is implementing a general license acknowledgement (GLA) pro_gram.

The GLA m:-ogram wi I require an persons who possess generally licensed (GL) devices under TRCR 40.61(a), "Certain Measuring, Gauging, and Controlling Devices"1 to file an application within 30 days of the date of receipt of the device. A review of the application \\Copy enclosed) will be made and 1f all information is complete, a GLA will be issued specifying limitations of possession and use. The limitations (i.e., leak testing intervals, testing intervals required for the "on-off" mechanism/indicator~person authorized to take the leak test wipe, etc.) will be derived from the Sealed Source and Device Kegistry (SSDR). If the SSDR is incomplete or uncfear concerning what is required and/or authorized, you may fina 1t beneficial to review the documents for their content ancf request appropriate changes from your regulatory agency.

As a manufacturer and/or distributor of GL devices, additional reporting r~uirements will be imP.Qsed by Part 41. Starting with the fourth quarter reporting period, the reports suomitted must contain the following:

the name and complete address of the general licensee and specific location of the device; the name of the Contact Person (CP) at the intended location of use. Preferably, the CP would be the individual who would be responsible hr ensuring compliance with regulatory requirements. If an intermediate person(s) will temporarily possess the device at the intended location of use prior to its possession by the end user, each intermediate person should be identified by name, address and relationship to the end user; the name of the manufacturer of the device; the model number of the device; the serial number of the device* /

the serial number of the sealed source; the radionuclide contained in each sealed source; and the activity of the radionuclide.

Alt.a'lough not required, any additional information regarding the devices (i.e., ship date, indication of source replacement ancf/or device repair, etc.) would be extremely beneficial and very much appreciated. As previously required1 the reports must be submitted within 30 days of the end of each calendar quarter. If n9 d~vices are distnbuted during the quarterly period, a report must be submitted indicating no devices were d1str1buted.

We a1rnreciate your cooperation in our endeavor to implement the GLA program. If we all work together, we will be able to ensure accountability of all GL devices and enhance the general licensee's compliance with the regulations.

~~

~~~

Industrial Program Division of Licensing, Registration and Standards Bureau of Radiation Control

Enclosures:

TRC Form 40-2 TRC Form 40-1 TRCR (mailed under separate cover)

\\e,(,1- -;::,..,,_

r'.., '

~i;;,/, ~ '_/::.'d-

~ ~

Alabama

/../..-31-f'?,

S-;3-73 1~ -;: -

,;'(:.,., ~ l/_~<-

~/3'ft{Krfiona.

~;3~/ic O,<

• bJ ~,,,.* f (' c" /'c, _ 1 *.,*., O<'?__._?fl *~

Arkansas

&+M:'"" uce, vf:'d,,lf.,J.

vK..

1' 9 =

,,,~----

Ca 1 if orn i a

'I/fl OK.

,<ev,Sn-3,,.£]v..,._,I n1,.,.,,*lw.('cV'J kii, Last Update Letter Sent Status Colorado ______

....;.:.{~~-*~r~J.~1~..;;.~~-'....... ~/~~~1/;..V~/--------0<~----------~c~x--'--

Connecticut r..,.,, _."/., i;*1

--* -,;Jo * ~,1 ':l.\\, 1 O, {t c:

• r -*- *i '/ *,1 : t Delaware 7/1/53

.6/1/:1/y_3 Z~r.&..e-6.-t..i( o,<.( "k,.e"'.;.

Florida. _______

.....,t'-l~'f'.~!.7 _________

.....;;~~,%~1/;3~V~1..;;.~ _____ ~x-.~~~c~<._ ___ _

Georgia ________

~~/,l~1~r~z1..._ ___________

a_A_~;;a_ _________

..;;.o_A:::~

Hawaii ________ -=~----------_i,/J~o~.-::=-_....,...,...;;;;::::=:;;;::;;;~=----

~:;::

I daho ll~-..ez

,I,;£,/ ~

t '

. J:X;l:---.. -

I 11 i no is r,

.; >,~

---

.......:~....... ---:~-------....... ~l,.-.;.-----~~~~~;:..:..;..-

1 nd i ana. ______

'-/./..;;.v_1.:;.:/J4.~f;-.=:-*~l:...l ';..' 1_?--'--------"-f-'-~'-,:;:;------'-.;l~~....:l...Ji,i~~ -

~

lowa ________

~1t..:::.:.t-/~,f~~~---------4f.qJ...t:.;2...-,,,,,,t.=::::....,........,,...Ja4 ¥:ic:::li~~..,.,~.;:..:;..;..::::

a Kansas 1

'7

~*J..:.

111111' Kentucky b/fi'

~~s:r..z,./N x-~

C~Mc"'

1.1 °)7(..i Louisiana n.rY 1/3ff3 U.ul ?d3/f:) &;;uc..-#..'J ~-m..-4..._

Maine

~d. -Y/9. y1,,J'Y1.A:..£.<-

Mary 1 and

• ./ 1 f.f'SD/(_

~;:__I:_

f5ic. -';",I Massachussetts;

/. 5-u... \\A1'i'Y.:. *

'* )----ffi chi gan

,/ ~

2 <-- -

Minnesota

,./ ~ 7~

Mississippi 1rJ':1

~-)?(.,-...u---

Missouri 1ifb

t. n-t.,,.-.L"--

• Montana 3/i,i

({ S/:*.,J

(/'iPo olZ). _ "y\\.,ce Nebraska

"',;(....,_.x,..

J Nevada rz..,....

7'~

New Hampshire

~'~-

New Jersey ____ -=,."-'¥~~,'laio.l.!./4"---t.:::.;;;,:..:.::.;_ ___

--,i.J.µ...._ ________

.L.:.::;~~~

New Mex i,:o 7(-s;IJ: 3 New York

};,.,u /4 1J~'ff::

c<-~7 uc.l 3/..i7

,/ ~0~

~

- Nortn Ca_r_o_l-,-. n_a ___ _,tr'""* f'.:..O _

C... 'u""'c.

.... * """~.-'- """11.;..1.;;;;.3.;;....;;.--i.:c-------'...;/?;..;,;_c,+(--'/;;;;;;..M..;;;.;t;_./;'.-"f)....

(,,,rx.,..,.(z_

~~:,

/ 'North *l)akota t,/f6 IJ/J/f 3 7l,* C$!, 1.c,.:.,,e 1., ~ Oh i o 27:N 711/r,3 7/.@'t-'> >,,._,,__

Ok 1 ahoma 3/xz 1//~J/ r,_3

£:u ::5"1f:7 3

,. 7; e,...,.<....__

Oregon 7/,51

.s?&t'?

l.,i *..1

• --------;*""'e.y"""n.:..I _________ ___..,,..__...._.__ ________

1'}-,----,/,----J.. f. / 1.~..,., ~

Pennsylvania I

zlc(lr.'>

K.,uA7;... 1 3

.:2 -<-"'5.1~~

Rhode Is 1 and I tz,*

,.,,1;;, 3

,&<-.A 71.,;i:.

,:;;;,ru...,L----

South Caro 1 i na

.,2/1l1',l(-,~(l..<..,il

(/..:.S-/cr 3 le,:,,{ 0i:

-. ~

.I' i

South Dakota. _____.....,. _________ _,....,..~--~'-.,_

---

.I..~nnessee S/d

.:,1(.:Ah -'

1°!..... ed. v/.1.~1

~-nt.....L(.

.,,u.c.,? <U( Texas 1'1)7 '71 t

*K..

}:,:.:.( /,.!.,._1,..,*<-1C.,

1/ >ru A..

y ri

.. Utah 1'1~*1 711 -1/r..?

,0,,,,.. l i1/-..(t*

¥ m.,,._,;z_

Vermont

'vJ/'1.">

r°['tn ;J.-aU*-:.;._--:,-

Virgin i a. ______

.:..l.:..C:3;..*~-- __________

7_. _ J.... /_'i'...;;?? _______

..;.1_c_'*:?:;z;.....,......;'1.,;;..'-;;.;;~....

_s _,.;..,~ * 'rc.e.,: Jc,._-*:

Washington 1'1-J'I:.

.n/.JJ 1 ?>

~

c.....<. :;;.J.1

i- -:171~'---

West Virginia. ___

~1.:..1_7.:..1 __________

~7...;'1.:..J.:..*....;~.:..>_..;.... __________

Wisconsin c/.2

.,1,- _.l,,*,; :i Wyoming _________________________________ _

measurex CORPORATION 21 JUNE 1991 Radiation Control Section State Health Division Department of Human Resources 1400 Southwest Fifth Avenue Portland, OR 97201 e

Gentlemen:

Our office is in the process of updating all State radiation regulations.

According to our files, the latest copy of regulations for your state is dated July 1987.

If there has been a recent revision, the radiation safety dept. would appreciate a copy sent to my attention.

Carol Kaiser Measurex Corp Radiation Safety Dept.

One Results Way Cupertino, CA. 95014 If there is a charge involved, please let me know so payment can be sent.

Your cooperation is greatly appreciated.

Ra~

Carol Kaiser Measurex Corporation Radiation safety Dept.

Secretary

/ck MEASUREX CORPORATION ONE RESULTS WAY CUPERTINO. CALIFORNIA 9501,.5991 (408) 255-1500

measurex CORPORATION 12 May 1993 Radiation Control Section State Health Division Department of Human Resources 800 N.E. Oregon Street Portland, OR 97232

Dear Sir:

Our office is in the process of upde~ing all State radiation regulations.

According to our files the latest copy of Oregon Rules for the Control of Radition for your state is dated July 1987.

If there is a more recent revision, please send a copy to my attention:

Joan Johanson Mea~urex Corporation Radiation Safety Department One Results Way Cupertino, CA 950l4 If there is a charge involved, please let me know.

Thank you for your assistance.

Sincerely,

~~KA/>~

~oan Johanson Radiation Safety Department MEASUREX CORPORATION ONE RESULTS WAY CUPERTINO. CALIFORNIA 95014-5991 (408) 255,1500

measurex CORPORATION 28 January 1994 Radiation Control Section State Health Division Department of Human Resources 800 N. E. Oregon Street Portland, OR 97232

Dear Sir:

Our office is in the process of updating all State radiation regulations.

According to our files the latest copy of regulations for your state (Oregon Rules for the Control of Radiation), is dated July 1987.

Do you have a more recent revision?

If you do, please send a copy to my attention:

Joan Johanson Measurex Corporation Radiation Safety Department One Results Way Cupertino, CA 950!4 If there is a charge involved, please let me know.

Thank you for your assistance.

Sincerely, Joan Johanson Radiation Safety Department MEASUREX COR=QRATION ONE RESULTS ',', !*

CUPERTINO. ::Ac =*:)RNIA 95014-5991

.JOB),55.1500 Measurex proposes that 10 CFR 150.31 be amended to read as follows (changes to the existing 10 CFR 150.31 are shown in bold type):

(a)

Prior to November 8, 1981, in the licensing and regulation of byproduct material, as defined in 150.3(c)(2) of this Part, or of any activity which results in the production of such byproduct material, an Agreement State shall require compliance with the requirements in Appendix A of 10 CFR 40 of this Chapter to the maximum extent practicable.

(b) After November 8, 1981, in the licensing and regulation of byproduct material, as defined in 150.3(c)(2) of this Part, or of any activity which results in the production of such byproduct material, an Agreement State shall require:

(1) Compliance with requirements in Appendix A of 10 CFR 40 of this Chapter established by the Commission pertaining to ownership of such byproduct material and disposal sites for such material; and (2)

Compliance with standards which shall be adopted by the Agreement State for the protection of the public health, safety, and the environment from hazards associated with such material which are equivalent, to the extent practicable, or more stringent than, standards in Appendix A of 10 CFR 40 of this Chapter adopted and enforced by the Commission for the same purposes, including requirements and standards subsequently promulgated by the Commission and the Administrator of the Environmental Protection Agency pursuant to the Uranium Mill Tailing Radiation Control Act of 1978; and (3)

Compliance with procedures which:

(i)

In the case of licenses, under State law include:

(A)

An opportunity, after public notice, for written comments and a public hearing, with a transcript; (B)

An opportunity for cross examination; and (C)

A written determination by the appropriate State official which is based upon findings included in such determination and upon the evidence presented during the public comment period and which is subject to judicial review; (ii)

In the case of rulemaking, provide an opportunity for public participation through written comments or a public hearing and provide for judicial review of the rule; (iii)

Require for each licensing action which has a significant impact on the human environment a written analysis by the appropriate State agency (which shall be available to the public before the commencement of any such proceedings) of the impact of such licensing action, including any activities conducted pursuant thereto, on the environment.

Such analysis shall include:

(A)

An assessment of the radiological and nonradiological impacts to the public health of the activities to be conducted pursuant to such licenses; (B)

An assessment of any impact on any waterway and groundwater resulting from such activities; (C)

Consideration of alternatives, including alternative sites and engineering methods, to the activities to be conducted pursuant to such license; and

(D)

Consideration of the long term impacts, including decommissioning, decontamination, and reclamation impacts associated with activities to be conducted pursuant to such license, including the management of any byproduct material, as defined in 150.3(c)(2) of this Part; and (iv)

Prohibit any major construction activity with respect to such material prior to complying with the provisions of paragraph (c)(3) of this section.

As used in this paragraph the term "major construction activity" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environment values.

(c)

After [date], in the licensing and regulation of byproduct material, as defined in 150.3(c)(2) of this Part, or of any activity which results in the production of such byproduct material, an Agreement State shall require compliance with procedures which:

(1)

Include the requirements of paragraph (b) of this section, and (2)

In the case of rulemaking also include:

(i)

Except as provided by paragraph (iv) of this section, when it proposes to adopt, amend, or repeal a regulation, shall submit notice of the proposed change to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Chief, Docketing and Service Branch.

(ii)

The notice will include:

(A)

Either the terms or substance of the proposed rule, or a specification of the subjects and issues involved; (B)

The manner, time, and place within which interested members of the public may comment, and a statement of where and when copies of such comments may be examined; (C)

The authority under which the regulation is proposed; (D)

The time, place, and nature of the public hearing, if any.

(iii)

The notice required in paragraph (i) of this section will be made not less than [number to be determined] days prior to the time fixed for hearing, if any, unless the Agreement State for good cause stated in the notice provides otherwise.

(iv)

The notice and comment provisions contained in paragraphs (i), (ii), and (iii) of this section will not be required to be applied -

(A)

To interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or (B)

When the Agreement State for good cause finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest, and are not required by statute. This finding, and the reasons therefor, will be incorporated into any rule issued without notice and comment for good cause.

(v)

The Agreement State shall provide for a 30-day post-promulgation comment period for -

(A)

Any rule adopted without notice and comment under the good cause exception on paragraph (iv)(B) of this section where the basis is that notice and comment is "impracticable" or

"contrary to the public interest."

(8) Any interpretative rule, or general statement of policy adopted without notice and comment under paragraph (iv)(A) of this section, except for those cases for which the Agreement State finds that such procedures would serve no public interest, or would be so burdensome as to outweigh any foreseeable gain.

(vi)

For any post-promulgation comments received under paragraph (v) of this section, the Agreement State shall submit a statement to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Chief, Docketing and Service Branch. This statement shall contain an evaluation of the significant comments and any revisions of the rule or policy statement made as a result of the comments and their evaluation.

(vii)

The Agreement State will afford interested persons an opportunity to participate through the submission of statements, information, opinions, and arguments in the manner stated in the notice. The Agreement State may grant additional reasonable opportunity for the submission of comments.

(viii) The Agreement State may hold informal hearings at which interested persons may be heard, adopting procedures which in its judgment will best serve the purpose of the hearing.

(ix)

When it has adopted, amended, or repealed a regulation, the Agreement State will submit notice of the action to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Chief, Docketing and Service Branch.

(x)

The notice of adoption, amendment, or repeal of a regulation provided by an Agreement State to fulfill the requirements of paragraph (ix) of this section will specify the effective date and include a concise general statement of the basis and purpose of the change. Such notice will be made not less than [number of days to be determined] days prior to the effective date, unless the Agreement State directs otherwise on good cause found and included in the notice of rulemaking provided in fulfillment of paragraph (x) of this section.

(d)

No Agreement State shall be required under paragraphs (b) or (c) to conduct proceedings concerning any license or regulation which would duplicate proceedings conducted by the Commission.

(e)

In adopting requirements pursuant to paragraph (b)(2) of this section, the State may adopt alternatives (including, where appropriate, site-specific alternatives) to the requirements adopted and enforced by the Commission for the same purpose if, after notice and opportunity for public hearing, the Commission determines that the alternatives will achieve a level of stabilization and containment of the sites concerned, and a level of protection for public health, safety and the environment from radiological and nonradiological hazards associated with the sites, which is equivalent, to the extent practicable, or more stringent than the level which would be achieved by standards and requirements adopted and enforced by the Commission for the same purpose and any final standards promulgated by the Administrator of the Environmental Protection Agency in accordance with section 275.

Alternative State requirements may take into account local or regional conditions, including geology, topography, hydrology and meteorology.

0 Measurex proposes that 10 CFR 2 be amended to add a section 2.810 that reads:

2.810 Notice of proposed rulemaking by Agreement States (a)

When the Commission, in fulfillment of the requirements of 150.31 (c)(2)(i) of this Part, receives Agreement State notice of a proposal to adopt, amend, or repeal a regulation, it will cause the notice to be published in the Federal Register. The publication of this notice will be made not less than fifteen (15) days prior to the time fixed for hearing, if any.

(b) When, the Commission, in fulfillment of the requirements of 150.31 (c)(2)(vi) of this Part, receives an Agreement State statement of post-promulgation comments, it will cause the statement to be published in the Federal Register.

(c) When, the Commission, in fulfillment of the requirements of 150.31(c)(2)(ix) of this Part, receives an Agreement State notice of the adoption, amendment, or repeal of regulations, it will cause the notice, including the effective date, to be published in the Federal Register.