[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Proposed Rules]
[Pages 56793-56794]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22699]


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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. 77, No. 179 / Friday, September 14, 2012 / 
Proposed Rules

[[Page 56793]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 30

[Docket Nos. 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; consideration in the rulemaking 
process.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) will consider the 
issue raised in the petition for rulemaking (PRM) submitted by Annette 
User, on behalf of GE Osmonics, Inc. (GE or the petitioner), in the 
rulemaking process. 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. In its review of the PRM, the NRC concluded that the 
petitioner raised a valid issue concerning regulatory control of the 
commercial distribution of PCTE membranes that the NRC will consider in 
its rulemaking process.

DATES: The docket for the petition for rulemaking, PRM-30-65, is closed 
on September 14, 2012.

ADDRESSES: Further NRC action on the issue raised by this petition can 
be found on the Federal rulemaking Web site at http://www.regulations.gov.
    You can access publicly available documents related to the 
petition, which the NRC possesses and are publicly available, using any 
of the following methods:
     Federal e-Rulemaking Web site: Public comments and 
supporting materials related to this petition can be found at http://www.regulations.gov by searching on the petition docket ID for PRM-30-
65 or NRC-2011-0134. Address questions about NRC dockets to Carol 
Gallagher; telephone: 301-492-3668, email: Carol.Gallagher@nrc.gov.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may access publicly available documents online in the NRC 
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the 
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's 
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to pdr.resource@nrc.gov. The ADAMS accession number 
for each document referenced in this notice (if that document is 
available in ADAMS) is provided the first time that a document is 
referenced.
     NRC's PDR: The public may examine, and have copied for a 
fee, publicly available documents at the NRC's PDR, Room O-1F21, 11555 
Rockville Pike, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-
0253; email: Edward.Lohr@nrc.gov.

SUPPLEMENTARY INFORMATION:

The Petition

    On April 20, 2011, the NRC received a PRM, filed by Annette User on 
behalf of GE Osmonics, Inc. (ADAMS Accession No. ML120250133). The 
petitioner requests that the NRC amend its regulations in parts 30 and 
33 of Title 10 of the Code of Federal Regulations (10 CFR), 
specifically 10 CFR 30.18, ``Exempt quantities,'' to allow commercial 
distribution and redistribution of PCTE membranes that have been 
irradiated with MFPs and are represented by the petitioner to contain 
such MFPs in quantities below the exempt quantity limits for byproduct 
material as identified in 10 CFR 30.71, Schedule B. On June 22, 2011 
(76 FR 36386), the NRC published a notice of receipt and request for 
comment for the PRM.
    Until February 2010, GE transferred the PCTE membranes to two GE 
redistribution facilities located in Westborough, Massachusetts and 
Minnetonka, Minnesota. During GE's Texas license renewal process, the 
Texas Department of State Health Services advised GE that it could no 
longer transfer the PCTE membranes to those two facilities for 
commercial distribution without an exempt distribution license from the 
NRC. In April 2011, GE submitted such a license application to the NRC 
and a petition for rulemaking that was docketed as PRM-30-65. The 
license application was returned to GE in June 2011, with no action 
taken because the NRC's current regulations do not allow exempt 
distribution of the PCTE membranes.
    The petition states that PCTE membranes are used in a wide variety 
of research, medical, academic, scientific, and industrial 
applications. In particular, PCTE membranes are used in pharmaceutical, 
medical device, and water filtration applications. The petitioner 
believes that the requested amendments are necessary to allow 
distribution of the PCTE membranes to the full range of its customers.

Public Comments on the Petition

    The notice of receipt of the PRM invited interested persons to 
submit comments. The comment period closed on September 6, 2011. The 
NRC received one comment letter (ADAMS Accession No. ML1178A021) from a 
member of the public opposing the PRM, stating that the current 
regulations do not place an unfair burden on the petitioner and have 
been in place for some time.
    The commenter's observation that the regulations do not place an 
unfair burden on the petitioner is consistent with the current 
regulations, which provide for an amendment process to add or subtract 
exempt materials or products such as those in 10 CFR 30.15. However, 
the NRC believes that the petitioner raised a valid concern that may 
warrant a regulatory solution that has not been specifically identified 
but could be accomplished through an amendment of the regulations.

Reasons for Consideration

    The NRC will consider the issue raised in the PRM in its rulemaking 
process because, based on the information GE has provided to date, the 
NRC believes that the issue may be resolved through the rulemaking 
process. However, due to current resource constraints, the NRC will not

[[Page 56794]]

be able to give the future rulemaking a high priority but will strive 
to complete it as resources are available.
    Although the petitioner requests the NRC to amend 10 CFR 30.18, the 
proposed amendment to the exempt quantities regulation may not be the 
best solution to resolve the issue raised in the petition. In the 
rulemaking process, the NRC will attempt to develop a technical basis 
to support an appropriate proposed rulemaking that would address the 
issue raised in the petition. If a technical basis to support a 
rulemaking cannot be developed, the issue will not be further 
considered by the NRC.
    The NRC tracks all rulemaking actions on its Web site at http://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/ and on the 
Federal rulemaking Web site, http://www.regulations.gov. The 
Regulations.gov Web site allows users to receive notifications when 
documents are added to a docket. To monitor further NRC action on the 
issue raised in PRM-30-65, register for notification under docket ID 
NRC-2011-0134. In addition, the NRC publishes a Unified Agenda, which 
is a semiannual compilation of all rules on which the NRC has recently 
completed action, has proposed action, or is considering action. The 
Unified Agenda may be found on the NRC's rulemaking Web site at http://www.nrc.gov/about-nrc/regulatory/rulemaking.html. As in all 
rulemakings, the NRC will solicit and consider public comments during 
the proposed rule phase of the rulemaking before determining the 
approach that will be the basis for the final rule.
    For the reasons cited in this document, the NRC will consider this 
petition as part of its rulemaking process.

    Dated at Rockville, Maryland, this 23rd day of August, 2012.
    For the Nuclear Regulatory Commission.
R.W. Borchardt,
Executive Director for Operations.
[FR Doc. 2012-22699 Filed 9-13-12; 8:45 am]
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