[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Proposed Rules]
[Pages 36386-36387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15593]
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Proposed Rules
Federal Register
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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. 76, No. 120 / Wednesday, June 22, 2011 /
Proposed Rules
[[Page 36386]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 30
[Docket No. PRM-30-65; NRC-2011-0134]
Petition for Rulemaking Submitted by Annette User on Behalf of GE
Osmonics, Inc.
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; receipt and request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is publishing for
comment a notice of receipt of a petition for rulemaking, dated April
18, 2011, which was filed with the NRC by Annette User on behalf of GE
Osmonics, Inc (the petitioner). The petition was docketed by the NRC on
April 20, 2011, and has been assigned Docket No. PRM-30-65. The
petitioner requests that the NRC amend its regulations regarding the
commercial distribution of byproduct material to allow recipients of
exempt quantities of polymer (polycarbonate or polyester) track etch
(PCTE) membranes that have been irradiated with mixed fission products
(MFP) to commercially redistribute the material without a license.
DATES: Submit comments by September 6, 2011. Comments received after
this date will be considered if it is practical to do so, but the NRC
is able to assure consideration only for comments received on or before
this date.
ADDRESSES: Please include Docket ID NRC-2011-0134 in the subject line
of your comments. For instructions on submitting comments and accessing
documents related to this action, see ``Submitting Comments and
Accessing Information'' in the SUPPLEMENTARY INFORMATION section of
this document. You may submit comments by any one of the following
methods:
Federal rulemaking Web site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-
2011-0134. Address questions about NRC dockets to Carol Gallagher,
telephone: 301-492-3668; e-mail: [email protected].
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
E-mail comments to: [email protected]. If you do
not receive a reply e-mail confirming that we have received your
comments, contact us directly at 301-415-1966.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852 between 7:30 a.m. and 4:15 p.m. during Federal workdays
(Telephone 301-415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
FOR FURTHER INFORMATION CONTACT: Cindy Bladey, Chief, Rules,
Announcements, and Directives Branch, Division of Administrative
Services, Office of Administration, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone: 301-492-3667, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
Submitting Comments and Accessing Information
Comments submitted in writing or in electronic form will be posted
on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove
any identifying or contact information, the NRC cautions you against
including any information in your submission that you do not want to be
publicly disclosed.
The NRC requests that any party soliciting or aggregating comments
received from other persons for submission to the NRC inform those
persons that the NRC will not edit their comments to remove any
identifying or contact information, and therefore, they should not
include any information in their comments that they do not want
publicly disclosed.
You can access publicly available documents related to this
document using the following methods:
NRC's Public Document Room (PDR): The public may examine
and have copied, for a fee, publicly available documents at the NRC's
PDR, Room O-1F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland 20852.
NRC's Agencywide Documents Access and Management System
(ADAMS): Publicly available documents created or received at the NRC
are available online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS,
which provides text and image files of the NRC's public documents. If
you do not have access to ADAMS or if there are problems in accessing
the documents located in ADAMS, contact the NRC's PDR reference staff
at 1-800-397-4209, or 301-415-4737, or by e-mail to
[email protected].
Federal Rulemaking Web Site: Public comments and
supporting materials related to this action can be found at http://www.regulations.gov by searching on Docket ID NRC-2011-0134.
Background
GE Osmonics, Inc. (GE) is a manufacturer of PCTE/MFP membranes.
PCTE membranes are irradiated with MFP in a GE-owned irradiator housed
inside a reactor at Texas A&M University. The irradiation is performed
by the university, under contract to GE and under Texas A&M NRC License
No. R-83, to produce an ion track. After irradiation and a period of
storage for decay, the university ships the PCTE/MFP membranes to GE's
Bryan, Texas facility, which receives, possesses, and processes the
membranes under a Texas Agreement State license. Byproduct material
which remains after decay is embedded/tightly bound in the membrane. At
the Bryan, Texas facility, GE chemically etches the membranes to
produce the desired pore size.
Until February 2010, GE transferred the PCTE/MFP membranes to two
GE redistribution facilities in Westborough, Massachusetts, and
Minnetonka, Minnesota. However, GE states that as part of the Bryan,
Texas license renewal process, the Texas Department of State Health
Services advised GE that it could no longer transfer the PCTE/MFP
membranes to those two facilities for commercial distribution without a
specific exempt distribution license from the NRC. GE states that it
has submitted such a license application to the NRC.
Annette User, on behalf of GE, submitted a petition for rulemaking
dated April 18, 2011, requesting that the NRC amend its regulations
regarding the
[[Page 36387]]
commercial distribution of byproduct material to allow recipients of
exempt quantities of PCTE/MFP to commercially redistribute the material
without a license. The petitioner states that once GE obtains an exempt
quantity distribution license from the NRC, there should be no
significant health, safety or common defense and security concerns that
would preclude its customers from further redistribution of the
material without a license.
The NRC has determined that the petition meets the threshold
sufficiency requirements for a petition for rulemaking under Title 10
of the Code of Federal Regulations (10 CFR), 2.802, and the petition
has been docketed as PRM-30-65. The NRC is requesting public comment on
the petition for rulemaking.
Discussion of the Petition
The petitioner states that under current NRC regulations (and with
a specific license, if approved), it is able to manufacture and
commercially distribute PCTE/MFP membranes to that segment of its
customers that will not be further distributing the product for
commercial purposes. However, current regulations at 10 CFR 30.18(c)
and (d) prohibit the petitioner from distribution of the material to a
substantial portion of its customer base that would commercially
redistribute the material if authorized to do so.
The petitioner proposes that 10 CFR 30.18 be modified as follows:
(c) This section does not authorize for purposes of commercial
distribution the production, packaging, repackaging, or transfer of
byproduct material or the incorporation of byproduct material into
products intended for commercial distribution, except as provided in
Sec. 30.18(f).
(d) Except as provided in Sec. 30.18(f), no person may, for
purposes of commercial distribution, transfer byproduct material in
the individual quantities set forth in Sec. 30.71 Schedule B,
knowing or having reason to believe that such quantities of
byproduct material will be transferred to persons exempt under this
section or equivalent regulations of an Agreement State, except in
accordance with a license issued under Sec. 32.18 of this chapter,
which license states that the byproduct material may be transferred
by the licensee to persons exempt under this section or the
equivalent regulations of an Agreement State.
(f) Polymer track etch membrane containing mixed fission
products in individual quantities, each of which does not exceed the
applicable quantity set forth in Sec. 30.71 Schedule B, may be
redistributed commercially to any person without the redistributor
obtaining a specific license under Sec. 32.18, so long as the
person who initially manufactures, processes, produces, packages,
repackages, or transfers quantities of byproduct material for
commercial distribution obtains a specific license under Sec.
32.18.
The petitioner has separately requested an NRC exempt distribution
license under 10 CFR 32.18 to authorize it to commercially distribute
the PCTE/MFP membranes to its customers, and believes that once it
obtains the license, there should be no significant health, safety or
common defense and security concerns that would preclude its customers
from further redistribution without a license. The petitioner included
an analysis in the petition for rulemaking document to support its
belief. The petitioner states that PCTE/MFP membranes are used in a
wide variety of research, medical, academic, scientific and industrial
applications. In particular, PCTE/MFP membranes are used in
pharmaceutical, medical device, and water filtration applications. The
petitioner believes that the amendments are necessary to allow it to
distribute the PCTE/MFP membranes to the full range of its customers.
Dated at Rockville, Maryland this 16th day of June, 2011.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2011-15593 Filed 6-21-11; 8:45 am]
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