2011-15593. 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.

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: [phone]; e-mail: [e-mail].
• Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
• E-mail comments to: [e-mail]. 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 [phone]).
• 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: [phone], e-mail: [e-mail].

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 [e-mail].
• 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 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 § 30.18(f).

(d) Except as provided in § 30.18(f), no person may, for purposes of commercial distribution, transfer byproduct material in the individual quantities set forth in § 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 § 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 § 30.71 Schedule B, may be redistributed commercially to any person without the redistributor obtaining a specific license under § 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 § 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.