Byproduct material; medical use: Authorized nuclear pharmacist and user qualification; training and experience requirements; rulemaking petition,

[Federal Register: October 28, 2004 (Volume 69, Number 208)]

[Proposed Rules]

[Page 62831-62832]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28oc04-17]

NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[Docket No. PRM-35-17]

Organization of Agreement States; Receipt of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; notice of receipt.

SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing a notice of receipt of a petition for rulemaking, dated September 3, 2004, which was filed with the Commission by Stanley Fitch, on behalf of the Organization of Agreement States (OAS). The petition was docketed by the NRC on October 1, 2004, and has been assigned Docket No. PRM-35-17. The petitioner requests that the NRC amend its regulations to specify the minimum number of didactic (classroom and laboratory) training hours required to meet the requirement for training and experience to qualify as an authorized nuclear pharmacist and an authorized user identified in the NRC's regulations on training for uptake, dilution, and excretion studies; imaging and localization studies; and use of unsealed byproduct material for which a written directive is required. This notice of receipt is being published for information only, not for public comment.

DATES: This petition for rulemaking was docketed on October 1, 2004.

ADDRESSES: The notice of receipt and any publicly available documents related to this petition may be viewed electronically on the public computers located at the NRC's Public Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Selected documents, including this notice of receipt, may be viewed and downloaded electronically via the NRC rulemaking Web site at http://ruleforum.llnl.gov. Address questions about our rulemaking Web site to

Carol

[[Page 62832]]

Gallagher (301) 415-5905; e-mail cag@nrc.gov.

Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this

site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of 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 Public Document Room (PDR) Reference staff at 1-800- 397-4209, 301-415-4737 or by e-mail to pdr@nrc.gov.

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone: 301-415-7163 or Toll Free 800-368-5642, or e- mail mtl@nrc.gov.

SUPPLEMENTARY INFORMATION:

Petitioner

The OAS is a nonprofit, voluntary, scientific and professional society incorporated in the District of Columbia. The membership of OAS consists of state radiation control directors and staff from the 33 Agreement States who are responsible for implementation of their respective radioactive materials programs. The purpose of the OAS is to provide a mechanism for these Agreement States to work with each other and with the NRC on regulatory issues associated with their respective agreements. Agreement States are those states that have entered into an effective regulatory discontinuance agreement with the NRC under subsection 274b. of the Atomic Energy Act (AEA). The role of the Agreement State is to regulate most types of radioactive material in accordance with the compatibility requirements of the AEA.

Discussion

The petitioner requests that the NRC amend its regulations in 10 CFR 35.55, 10 CFR 35.190, 10 CFR 35.290, and 10 CFR 35.390, specify the minimum number of didactic (classroom and laboratory) training hours for the authorized nuclear pharmacists and the authorized users identified in these sections. The NRC revised 10 CFR Part 35, Medical Use of Byproduct Material, on April 24, 2002. The revised training and experience requirements in 10 CFR 35.55, 35.190, 35.290 and 35.390 require training and experience to include both classroom and laboratory training and supervised work experience, but there is no specified breakdown in these sections of these hours. The petitioner states that, in the current regulations, minimum numbers of didactic training hours for radiation safety training are not specified or separated from the total training hours. Part 35, Subpart J (which was reinserted into the current rule but will expire in October 2005), does specify a minimum number of classroom and laboratory training hours and supervised work experience.

The petitioner believes that the lack of clearly defined didactic (i.e., classroom and laboratory) training hours for this rule weakens the rule's consistency and uniformity. The petitioner further believes that need for specified didactic training hours is a radiation safety issue rather than a ``practice of medicine'' issue. The petitioner also believes that radiation safety for the patient and the occupational radiation workers may be compromised. The petitioner states that a majority of radiation safety principles and procedures are learned during this classroom and laboratory training. The petitioner also asserts that the inclusion of a specification for a minimum number of hours of classroom and laboratory training (`didactic' training), in Sec. Sec. 35.55, 35.190, 35.290, and 35.390, will increase consistency and uniformity of requirements between States and make it easier to maintain regulations that are consistent with the NRC's designation of requirements for training and experiences as compatibility category B.

Conclusion

The NRC is currently revising the training and experience requirements of Part 35. Among the issues being addressed in the current rulemaking is whether a minimum number of didactic training hours should be defined and specified in Sec. Sec. 35.55, 35.190, 35.290 and 35.390. Therefore the NRC will address the issues raised in this petition as part of the ongoing rulemaking, ``Medical Use of Byproduct Material--Recognition of Speciality Boards (RIN No. AH19).'' A proposed rule was published in the Federal Register on December 9, 2003 (68 FR 68549). Because the issues raised by this petition are being considered in a current rulemaking, NRC is not instituting a separate public comment period for this action.

Dated at Rockville, Maryland, this 22nd day of October 2004.

For the Nuclear Regulatory Commission. Annette Vietti-Cook, Secretary of the Commission.

[FR Doc. 04-24097 Filed 10-27-04; 8:45 am]

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