Rulemaking petitions: Angel, Jeffery C.,

[Federal Register: August 23, 1999 (Volume 64, Number 162)]

[Proposed Rules]

[Page 45907-45908]

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

[DOCID:fr23au99-21]

NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[Docket No. PRM-35-15]

Jeffery C. Angel; Receipt of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; Notice of receipt.

SUMMARY: The Nuclear Regulatory Commission (NRC) has received and requests public comment on a petition for rulemaking filedby Jeffery C. Angel. The petition has been docketed by the Commission and has been assigned Docket No. PRM-35-15. The petitioner requests that the NRC amend its regulations concerning the medical use of byproduct material to prohibit the hand-held administration of radiopharmaceuticals by injection and to require the use of the Angel Shield, a device to administer radioactive substances. The petitioner requests that the NRC take this action to make the administration of radiopharmaceuticals by injection safer.

DATES: Submit comments by November 8, 1999. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date.

ADDRESSES: Submit comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Attention: Rulemakings and Adjudications staff.

Deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm on Federal workdays.

For a copy of the petition, write to David L. Meyer, Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

You may also provide comments via the NRC's interactive rulemaking website at http://ruleforum.llnl.gov. This site provides the capability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking website, contact Ms. Carol Gallagher, (301) 415-5905 (e-mail: CAG@nrc.gov).

FOR FURTHER INFORMATION CONTACT: David L. Meyer, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Telephone: 301-415-7162 or Toll-free: 1-800-368-5642 or E-mail: DLM1@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Background

On June 29, 1999, the Nuclear Regulatory Commission (NRC) received a petition for rulemaking submitted by Jeffery C. Angel. The petitioner requests that the NRC amend its regulations concerning the medical use of byproduct material to prohibit the hand-held administration of radiopharmaceuticals by injection and require the use of the Angel Shield, a device to administer radioactive substances. The petitioner requests that the NRC take this action to make the administration of radiopharmaceuticals by injection safer. The petition has been docketed as PRM-35-15. The NRC is soliciting public comment on the petition for rulemaking.

The NRC's regulations governing the medical use of byproduct material appear in 10 CFR Part 35. Paragraph (c) of Sec. 35.60 requires that an individual use a syringe radiation shield when administering a radiopharmaceutical by injection unless the use of the shield is contraindicated for that patient or human research subject.

Discussion

The petitioner states that the current practice of placing the radiopharmaceutical into a syringe radiation shield and delivering a hand-held injection places the person administering the substance in direct

[[Page 45908]]

and immediate contact with the radiopharmaceutical. The petitioner contends that this practice results in the unnecessary exposure of this individual to radiation. The petitioner asserts that the design and engineering of syringe radiation shields is not based on sound radiation protection principles. The petitioner further states that current syringe designs violate the fundamental radiation principles of time, shielding, and distance. The petitioner states that syringe radiation shields provide inadequate radiation protection because--

1. They are hand held, thereby placing an administrator in direct and immediate contact with the radioactive substance;

2. They must be light enough so that they are not cumbersome to work with and consequently, they do not incorporate enough shielding to protect administrators adequately; and

3. There is no shielding at the distal or proximal portions of the shield, which results in direct and unnecessary radiation exposure.

   The petitioner refers to the provisions of 10 CFR 20.1101(b) that require licensees to use procedures and engineering controls based on sound radiation protection principles to achieve occupational dose rates that are as low as is reasonably achievable (ALARA).

   The Petitioner's Request

   The petitioner requests that the NRC amend its regulations concerning the medical use of byproduct material to prohibit the hand- held administration of radiopharmaceuticals by injection. As an alternative, the petitioner suggests that the NRC require the use of the Angel Shield, a radioactive substance administrator that eliminates the hand-held administration of radiopharmaceuticals by injection. The petitioner believes that radiation exposure rates would be immediately and substantially reduced through the use of the Angel Shield. The petitioner asserts that the Angel Shield reduces radiation exposure by--

1. Eliminating the hand-held injection of radiopharmaceuticals;

2. Encapsulating the syringe within the administrator completely thereby providing 360 degrees of protection;

3. Shielding 100 percent of low-energy emissions (140 kev) and 88 percent of high-energy emissions (511 kev);

4. Allowing for the remote administration of the radiopharmaceutical; and

5. Reducing the number of missed injections and subsequent multiple exposures.

   The petitioner explains that the Angel Shield uses \1/2\-inch lead walls that completely encapsulate the radiopharmaceutical. The petitioner further explains that the entire administration process is mechanized. This removes the occupational worker from direct and immediate contact with the radioactive substance. As a result, radiation exposure rates are substantially and immediately reduced.

   The petitioner contends that the reduction of unnecessary radiation exposure when administering radiopharmaceuticals by injection is of critical importance as the practice of nuclear medicine evolves toward therapeutic applications and the administration of medium and high- energy radiopharmaceuticals. The petitioner states that the one of the NRC's primary duties is to establish regulations on the safe use of nuclear materials. The petitioner contends that prohibiting the hand- held administration of radiopharmaceuticals by injection and requiring the use of the Angel Shield makes the administration of radiopharmaceuticals safer and furthers the goals of ALARA by reducing occupational dose rates.

   The Petitioner

   The petitioner has been a nuclear medicine technologist for over twenty years and has been exposed to radiation on a recurrent daily basis. He invented a radioactive substance administrator, the Angel Shield, to protect himself and others from unnecessary radiation exposure when administering radiopharmaceuticals by injection.

   Dated at Rockville, Maryland, this 17th day of August, 1999.

   For the Nuclear Regulatory Commission. Andrew L. Bates, Acting Secretary of the Commission.

   [FR Doc. 99-21792Filed8-20-99; 8:45 am]

   BILLING CODE 7590-01-P