[Federal Register Volume 61, Number 118 (Tuesday, June 18, 1996)]
[Proposed Rules]
[Pages 30837-30839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15395]



========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

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Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / 
Proposed Rules

[[Page 30837]]



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 <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="c4899088848a9687ea838b92">[email protected]</a>.

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 Sec. 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 Sec. 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 
Sec. 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

[[Page 30838]]

version of Sec. 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 Sec. 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 Sec. 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 Sec. 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 self-certify 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 Sec. 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

[[Page 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 on-line 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 AXD<a href="/cdn-cgi/l/email-protection#7043301e02135e171f06"><span class="__cf_email__" data-cfemail="2013604e52430e474f56">[email protected]</span></a>.
    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

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