[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]
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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.
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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 [email protected]
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 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
