[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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