Daily Rules, Proposed Rules, and Notices of the Federal Government
* Federal e-Rulemaking Web site: Public comments and supporting materials related to this petition can be found at
* NRC's Agencywide Documents Access and Management System (ADAMS): You may access publicly available documents online in the NRC Library at
* 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.
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
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.
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.
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
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
For the reasons cited in this document, the NRC will consider this petition as part of its rulemaking process.
For the Nuclear Regulatory Commission.