This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

30837

Vol. 61, No. 118

Tuesday, June 18, 1996

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 34

[Docket No. PRM–34–5]

Amersham Corporation, Receipt of

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 Amersham

Corporation. The petition has been

docketed by the Commission and

assigned Docket No. PRM–34–5. The

petitioner requests that the NRC amend

its regulations by removing the

reference to ‘‘associated equipment’’

from the radiography equipment

regulations. The petitioner believes that

this amendment would clarify the

licensing reviews of sealed sources and

radiographic exposure devices to meet

the applicable requirements.

DATES: Submit comments by September

3, 1996. Comments received after this

date will be considered if it is practical

to do so, but assurance of consideration

cannot be given except to those

comments received on or before this

date.

ADDRESSES: For a copy of this 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–

0001.

Submit comments to: Secretary, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001. Attention:

Docketing and Services Branch.

Deliver comments to 11555 Rockville

Pike, Rockville, Maryland, between 7:30

am and 4:15 pm on Federal workdays.

For information on submitting

comments electronically, see

‘‘Electronic Access’’ under the

Supplementary Information section of

this notice.

FOR FURTHER INFORMATION CONTACT: Don

Nellis, Office of Nuclear Regulatory

Research, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Telephone: (301) 415–6257, or

Michael T. Lesar, Office of

Administration, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Telephone: (301) 415–7163 or Toll

Free: 800–368–5642, or E-mail

MTL@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Background

The NRC received a petition for

rulemaking dated March 28, 1996,

submitted by Amersham Corporation.

The petition was docketed as PRM–34–

5 on April 8, 1996. The petitioner

requests that the NRC amend its

regulations governing performance

requirements for radiography equipment

in 10 CFR Part 34.

Petitioner’s Request

Amersham Corporation requests that

the NRC amend its regulations to

remove reference to ‘‘associated

equipment’’ from § 34.20 so that

continued inspection and enforcement

of the rule would be performed on the

basis of source and device reviews only.

The petitioner believes that the current

good operating history and safety record

of the associated equipment, when it is

used and maintained properly, supports

this action. The petitioner further

requests that § 34.28 be amended to

reflect appropriate inspection and

maintenance requirements for all of the

radiography equipment, including

associated equipment.

Discussion of the Petition

The petitioner believes that the

current regulations for radiography

equipment standards are not clearly

defined; thereby resulting in confusion

and noncompliance on the part of the

users. The petitioner believes that

interpretation of the regulation by the

NRC has led to an undocumented

requirement for reviews of the

associated equipment used by the

radiography industry in addition to the

reviews of sealed sources and

radiographic exposure devices. The

petitioner states that the NRC has

expanded its reviews to cover associated

equipment without any formal

rulemaking taking place, even though

§ 32.210 applies to the evaluation of

sealed sources and devices and not to

other equipment. The petitioner asserts

that because of the undocumented

definition that ‘‘associated equipment’’

is anything that comes into direct

contact with the source, the rule in

being interpreted and implemented

inconsistently.

The petitioner states that ANSI N432,

the standard referenced in Part 34, was

originally written as guidance for

manufacturers on the design and

manufacture of standard radiography

equipment. Amersham Corporation, a

member of the ANSI committee,

recently discussed the original intent of

this standard with other committee

members who agreed the original intent

was to serve as guidance for good

manufacturing practices and not as a

regulatory approval checklist. When the

NRC included the standard in Part 34,

the industry did not foresee that

regulatory approval would cover

associated equipment in detail.

NRC requested that Amersham’s

associated equipment (standard controls

and guide tubes) be approved under the

affected device registrations, specifically

listed on the device sheet by model

number. The petitioner states that it

realized later that the inclusion of the

associated equipment in the regulations

placed unexpected restrictions on

manufacturers and users.

The petitioner understands that

Agreement States do not require that the

associated equipment be listed and

approved on the device registration

sheet as part of the radiography system

for the other manufacturers. The

petitioner believes that this raises

several issues, in addition to putting it

at a significant competitive

disadvantage. The petitioner indicates

that this inconsistency highlights the

confusion in the way the rule is being

interpreted and implemented for

associated equipment. The petitioner

states that it adds confusion on the part

of users too, concerning regulatory

compliance, when similar items are

treated in different ways depending on

the manufacturer’s licensing body.

The petitioner also claims that there

is another undocumented requirement

that users or manufactures cannot

perform their own certification of

associated equipment. The current
30838 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Proposed Rules

version of § 34.20 only requires that the

equipment meet ANSI N432; it does not

state that regulatory approvals are

needed to comply with this regulation.

The petitioner believes that these

interpretations are a broad stretch of the

original intent of Part 34. The petitioner

states that if these are the NRC’s formal

interpretations of the provisions, they

should be submitted as a proposed rule

change because they are significantly

more restrictive than the current

wording of § 34.20 allows and constitute

a substantial change in what was the

standard practice for sealed source and

device reviews.

The petitioner states that since the

effective date of the amendments to

§ 34.20, it has recognized the negative

impact in the following areas:

Increased exposures. The petitioner

states that because collimators are not

being used currently in many of the

applications in which they were used

before the regulation became effective,

there are increased exposures to

personnel. Most collimators have not

been approved by the NRC or an

Agreement State to meet Part 34 because

the industry was not aware that the NRC

would require testing, a full safety

review, and regulatory approval to gain

Part 34 endorsement for these parts.

Therefore, no approvals were sought

before the regulation’s effective date.

The petitioner asserts that some users

are shut down because they are

authorized only to conduct radiography

with collimators, and approved

collimators are not available. In other

cases, to keep exposures as low as

reasonable achievable (ALARA) as is

also required by NRC regulations, users

are continuing to work with unapproved

collimators. The petitioner asserts that

there have been no significant safety

problems with the use of collimators in

the past.

Economic considerations. The

petitioner states that a manufacturer or

user in an NRC state must pay a

substantial fee to get approvals for the

associated equipment. In addition to the

fees, some users are purchasing testing

equipment or hiring professional

engineers to prove a piece of equipment

that has been in use for the last twenty

years can now be deemed safe after it

has been reviewed by the NRC. The

petitioner states that fees, the cost of

new equipment, and inconsistent

interpretations and subsequent

enforcement, puts NRC licensees at a

competitive economic disadvantage

because Agreement states do not require

Part 34 compliance for the associated

equipment.

Enforcement. The petitioner asserts

significant differences exist in the level

of enforcement implemented by the

various Agreement States and different

NRC regions. Some users have been

required to go to extraordinary measures

to prove a piece of equipment meets

Part 34 requirements; in other cases the

regulatory authority is not concerned

about the associated equipment. The

petitioner notes that because the

inspection guidelines for inspecting

against the new rule have not been

documented, demonstrating compliance

is very difficult.

Inability to perform required work.

The petitioner states that some licensees

require specialized equipment to

perform radiography, such as J-tubes, jet

engine probes, and other rigid source

stops. Under the current interpretation

of § 34.20, all specialized equipment

must be approved. No user or

manufacturer fully understood that all

associated equipment, including the

specialized equipment, was covered by

the rule; therefore, no approvals were

sought. Manufacturers believed only a

listing of models or a generic

description of the specialized

equipment would be needed to get Part

34 endorsement.

Reasons for the Petition

The petitioner states that the

associated equipment currently in use

has a good operational safety history. To

prevent licensees from using

unacceptable equipment, the petitioner

believes they should be required to

certify that any equipment used in

conjunction with a source or device be

able to withstand the environment and

use that is expected, using the ANSI

N432 standard as a baseline.

The petitioner believes ANSI N432

should be used as guidance for the

associated equipment not as a regulatory

approval checklist. Considering all the

years of manufacturing experience and

that none of the associated equipment is

deemed critical to safety, there is no

need to perform an additional outside

review. The petitioner believes that the

manufacturer should be allowed to selfcertify that the associated equipment is

fit for use, whether the certification is

based on testing in accordance with

ANSI, relying on a good operational

history, or comparing it to a similar

component.

The petitioner notes that there are

some specific applications and

environments in which the ANSI

requirements cannot be physically met,

but the part is still fit for use. The

petitioner believes that it is important

that fitness for use be considered

regardless of the ANSI standard because

it will result in a safer product being

used.

The petitioner states that the

regulatory review adds considerable

costs to the user and the manufacturer,

without increased safety to the user or

the general public. Regulatory review

will not result in the manufacturer

changing the design or method of

manufacture for the associated

equipment that has been used

successfully from an operational and

safety standpoint for the last 40 years.

The petitioner believes very strongly

in the importance of proper inspection

and maintenance of all the equipment.

The petitioner recognizes that 75

percent of customer complaints or

problems were the result of inadequate

maintenance, improper use, or damage.

The petitioner states that the majority of

problems that have occurred in the field

could have been prevented by requiring

that proper inspection and maintenance

be performed and that defective

equipment be taken out of use. The

petitioner has not seen many problems

as a result of basic design or

construction of the equipment.

Conclusion

The petitioner believes that ANSI

N432 is the appropriate reference for

equipment requirements; however, it

disagrees with the current NRC

interpretation that associated equipment

requires a regulatory review. The

petitioner requests that the NRC clarify

its interpretation. If the definition of a

sealed source and device in § 32.210 is

being expanded to cover the associated

equipment, the petitioner believes it

must go through a rulemaking change

before it becomes a requirement.

Because the current interpretation is

having a significant economic impact on

the entire industry, causing some

programs to shut down until it is

resolved, the petitioner requests that the

NRC temporarily rescind this

requirement until it can be clarified.

Electronic Access

Comments may be submitted

electronically, in either ASCII text or

WordPerfect format (version 5.1 or

later), by calling the NRC Electronic

Bulletin Board (BBS) on FedWorld. The

bulletin board may be accessed using a

personal computer, a modem, and one

of the commonly available

communications software packages, or

directly via Internet. Background

documents on this petition also are

available for downloading and viewing

on the bulletin board.

If using a personal computer and

modem, the NRC rulemaking subsystem

on FedWorld can be accessed directly

by dialing the toll-free number 800–

303–9672. Communication software
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Proposed Rules 30839

parameters should be set as follows:

parity to none, data bits to 8, and stop

bits to 1 (N,8,1). Using the ANSI or VT–

100 terminal emulation, the NRC

rulemaking subsystem can then be

accessed by selecting the ‘‘rules menu’’

option from the ‘‘NRC main menu.’’

Users will find the ‘‘FedWorld On-line

User’s Guides’’ particularly helpful.

Many NRC subsystems and data bases

also have a ‘‘Help/Information Center’’

option that is tailored to the particular

subsystem.

The NRC subsystem on FedWorld also

can be accessed by a direct-dial

telephone number for the main

FedWorld BBS, (703) 321–3339, or by

using Telnet via Internet: fedworld.gov.

If using (703) 321–3339 to contact

FedWorld, the NRC subsystem will be

accessed from the main FedWorld menu

by selecting the ‘‘Regulatory,

Government Administration and State

Systems,’’ then selecting ‘‘Regulatory

Information Mall.’’ At that point, a

menu will be displayed that has an

option ‘‘U.S. Nuclear Regulatory

Commission’’ that will take you to the

NRC on-line main menu. The NRC online area also can be accessed directly

by typing ‘‘/go nrc’’ at a FedWorld

command line. If you access NRC from

FedWorld’s main menu, you may return

to FedWorld by selecting the ‘‘Return to

FedWorld’’ option from the NRC on-line

main menu. However, if you access NRC

at FedWorld by using NRC’s toll-free

number, you will have full access to all

NRC systems, but you will not have

access to the main FedWorld system.

If you contact FedWorld using Telnet,

you will see the NRC area and menus,

including the rules menu. Although you

will be able to download documents

and leave messages, you will not be able

to write comments or upload files

(comments). If you contact FedWorld

using FTP, all files can be accessed and

downloaded but uploading files is not

allowed; you will only see a list of files

without descriptions (normal gopher

look). An index file listing all files

within a subdirectory and descriptions

of those files, is available. There is a 15-

minute time limit for FTP access.

Although FedWorld also can be

accessed through the Worldwide Web,

like FTP, that mode only provides

access for downloading files and does

not display the NRC rules menu.

For more information on NRC bulletin

boards call Mr. Arthur Davis, Systems

Integration and Development Branch,

NRC, Washington, DC 20555–0001,

telephone (301) 415–5780; e-mail

AXD3@nrc.gov.

Single copies of this petition may be

obtained by written request or telefax

((#01) 415–5144) from: Rules Review

Section, Rules Review and Directives

Branch, Division of Freedom of

Information and Publications Services,

Office of Administration, Mail stop T6–

D59, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Certain documents related to this

petition, including comments received,

may be examined at the NRC Public

Document Room, 2120 L Street NW.

(Lower Level), Washington, DC. These

same documents may also be viewed

and downloaded electronically via the

Electronic Bulletin Board established by

NRC for this petition as indicated above.

Dated at Rockville, Maryland, this 12th day

of June, 1996.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 96–15395 Filed 6–17–96; 8:45 am]

BILLING CODE 7590–01–P

10 CFR Parts 150 and 170

RIN 3150–AF49

Recognition of Agreement State

Licenses in Areas Under Exclusive

Federal Jurisdiction Within an

Agreement State

AGENCY: Nuclear Regulatory

Commission.

ACTION: Proposed rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is proposing to

amend its regulations to clarify that

Agreement State licensees can seek

reciprocal recognition of their license

from the NRC when they are working

within areas of exclusive Federal

jurisdiction in Agreement States. The

proposed amendments would also

clarify NRC regulatory requirements for

reciprocity and the appropriate fees and

filing procedures applicable to

Agreement State licensees operating

under reciprocity.

DATES: The comment period expires

September 3, 1996. Comments received

after this date will be considered if it is

practical to do so, but the Commission

is able to assure consideration only for

comments received on or before this

date.

ADDRESSES: Send comments to:

Secretary, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Attention: Docketing and Service

Branch.

Hand deliver comments to: 11555

Rockville Pike, Rockville, Maryland,

between 7:45 am and 4:15 pm on

Federal workdays.

For information on submitting

comments electronically, see the

discussion under Electronic Access in

the Supplementary Information Section.

Certain documents related to this

rulemaking, including comments

received, may be examined at the NRC

Public Document Room, 2120 L Street

NW. (Lower Level), Washington, DC.

These same documents may also be

viewed and downloaded electronically

via the Electronic Bulletin Board

established by NRC for this rulemaking

as discussed under Electronic Access in

the Supplementary Information Section.

FOR FURTHER INFORMATION CONTACT:

Hampton Newsome, Office of the

General Counsel, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone (301) 415–

1623, e-mail HHN@nrc.gov or Mark

Haisfield, Office of Nuclear Regulatory

Research, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001, telephone (301) 415–6196, e-mail

MFH@nrc.gov.

SUPPLEMENTARY INFORMATION:

Background

Currently, subject to certain

restrictions, any person who holds a

specific license from an Agreement

State may conduct activities permitted

by that license in non-Agreement States

and offshore waters using an NRC

general license. The general license is

granted under the authority contained

in 10 CFR 150.20, ‘‘Recognition of

Agreement State Licenses.’’ To meet the

requirements of § 150.20, licensees must

submit an NRC Form 241 at least 3 days

before engaging in the activities (subject

to some exceptions as noted in

§ 150.20). If an Agreement State licensee

does not qualify for a general license

under § 150.20, the licensee must apply

for and obtain a specific license to work

in areas of NRC jurisdiction.

Need for Proposed Regulatory Action

The NRC believes that there are

several problems with the current

regulations in § 150.20 that necessitate a

rulemaking. First, the current regulation

does not include provisions to allow

Agreement State licensees to qualify for

an NRC general license when operating

in areas of exclusive Federal jurisdiction

within Agreement States. Second, there

has been some confusion regarding the

NRC regulations applicable to

Agreement State licensees operating in

areas of NRC jurisdiction pursuant to

§ 150.20. Third, § 150.20 does not

reference the appropriate fee

requirements applicable to Agreement

State licensees who file an NRC Form

241. Finally, there has been some

confusion regarding the filing

procedures for an NRC Form 241.