ML20217C525

Forwards Copy of Petition for Rulemaking Requesting NRC to Amend Regulations Concerning Medical Use of Byproduct Matl (PRM-35-15).Petition Filed with NRC by Jc Angel.Copy of Fr Notice,Included

ML20217C525
Person / Time
Issue date:	08/23/1999
From:	Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA)
To:	J. J. Barton, Inhofe J HOUSE OF REP., SENATE
References
RULE-PRM-35-15 NUDOCS 9910130280
Download: ML20217C525 (2)

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WASHINGTON, D.C. 20656 4001 1

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j August 23, 1999 The Honorable Joe L Barton, Chairman Subcommittee on Energy and Power j

Committee on Commerce United States House of Representatives

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Washington, DC 20515

Dear Mr. Chairman:

i Enclosed for your information is a copy of a petition for rulemaking requesting that the Nuclear Regulatory Commission (NRC) amend its regulations concerning the medical use of byproduct material (PRM-35-15). The petition was filed with the NRC by Jeffery C. Angel.

The petitioner requests that the NRC amend its regulations 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.

4 Also enclosed is a copy of the Federal Register notice for the petition that contains additional information concerning the petition. The notice will be published requesting public comment for a 75-day period.

Sincerely,

[

Dennis K. Rathbun, Direc'or Office of Congressional Affairs

Enclosures:

1. PRM 35-15

2. Federal Register notice cc: Ralph M. Hall l

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_ NUCLEAR REGULATORY COMMISSION

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' The Honorable ' James M. Inhofe, Chairman

- Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Public Works-United States Senate i

Washington, DC 20510

Dear Mr. Chairman:

Enclosed for your information is a copy of a petition for iulemaking requesting that the Nuclear Regulatory Commission (NRC) amend its regulations concerning the medical use of byproduct material (PRM-35-15). The petition was filed with the NRC by Jeffery C. Angel.

The petitioner requests that the NRC amend its regulations 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.

Also enclosed is a copy of the Federal Register notice for the petition that contains additional information concerning the petition. The notice will be published requesting public comment for a 75-day period.

Sincerely, if Dennis K. Rathbun, Director Office of Congressional Affairs Enclosuree

1. PRM 3515 O

2. Federal Register notice l

cc: Senator Bob Graham i

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fkEh RADIATION PROTECTION DEVICE A RADIOACTIVE SUBSTANCE ADMINISTRATOR PETITION TO AMEND 10 CFR 35.60 (c)

PROBLEM STATEMENT Radiation exposure when administering radiopharmaceuticals by injection. The current pratice is to place the radiopharmaceutical into a syrinEs radiation shleid and deliver a hand held injection. This places

' the Individual in direct and immediate contact with the radioactive substance resulting in unnecessary radiation exposure.

PROBLEM SOLUTlON The Angel Shield, A Radioactive Substance Administrator eliminates hand held administration of radiopharmaceuticals by injection. As a result, radiation exposure rates will be immediately and substantially reduced.

REDUCES RADIATION EXPOSURE BY:

1. Eliminating hand held injections of radiopharmaceuticals.

2. Complebly encapsulating the syringe within the administrator providing 360 degrees of protection.

3. Shielding 100% of low energy (140 key) and 88% of high energy (311 kev).

4. Allowing fer the remote adrainistration of the radiopharmaceutical.

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

RELEVANT STATUTES

.10 CFR 20.1101 (b) requires all licensees to use procedures and engineering controls based upon sound radiation protection principles to achieve occupational dose rates that are as low as is reasonably achievable (ALARA). Prior to the Angel Shield the only radiation protection occupational workers had when administering radiopharmaceuticals by injection was syringe radiation shields.

10 CFR 35.60 (c) requires each Individual to use a syringe radiation shleid when administering a radiopharmaceutical by injection.

Unfortunately, syringe radiation shleids are not designed nor engineered based upon sound radiation protection principles. In fact, they violate the fundamental radition protection principles of time, distance, and shielding.

MY GROUNDS FOR AND INTEREST IN THE ACTION t

REQUESTED 1 have been a Nuclear medicine technologist for over twenty years and th '

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N I have been a Nuclear medicine technologist for over twenty years and have been exposed to radiation on a recurrent daily basis. I invented the Angel Shleid, a radioactive substance administrator to protect myself and all others similarly situated from unnecessary radiation exposure when administering radiopharmaceuticals by injection. This is of critical importance as the practice of Nuclear Medicine evolves teward therapeutic applications and the administration of medium and high energy radiopharmaceuticals. Additionally, with the advent of Molecular C,oincidence Imaging and the increased use of FDG (511 key), the need for greater radiation protection becomes emergent. The Angel Shield utilizes 1/2". lead walls that completely encapsulates the radlopharmaceutical and provides 100% shleiding for low energy (140 key) and 88% shielding of high energy (511 key) emissions. The entire administration process is mechanized thereby removing the occupational I worker from direct and immediate contact with the radiactive substance. in so doing, radiation exposure rates will be substantially and immediately reduced. STATEMENTS IN SUPPORT OF THE PETITION Syringe radiation shields are not designed or engineered based upon sound radiation protection principles They violate the fundamental radiation protection principles of time, distance, and shielding. They are inadequate radiation protection devices for the following reasons:

1. They are hand held thereby placing the individual in direct and immediate contact with the radioactive substance

2. They are designed to be hand held, as such they must be light so as not to be cumbersome to work with, consequently they do not incorporate enough shielding to adequately protect the Individual.

3. There is no shleiding or radiation protection at the distal or proximal portions of the shield resulting in unhampered and unnecessary radiation exposure.

The Angel Shield is the only radiation protection device on the market Sat is designed and engineered based upon sound radiation protection prinalples. It is the first and only device that successfully incorporates the radiation protection principles of time, distance, and shielding into a ) i safe, easy to use, and affordable radloactive substance administrator, Please refer to the accompanying brochure for a detailed ex . nation on the mode of operation of the Angel Shleid. Not shown in the brochure is secondary shielding which rises from the base of the stand to the horizontal portion of the stand. The secondary shielding is used to protect the Individual from any residual activity remaining in the connector subsequent to administration. Also not shown is a clamp which allows the stand to'be attached to an IV pole so the Angel Shield can be conveniently rolled to wherever the radiopharmaceutical will be administered..

l i Based on the above, I petition you to prohlblt hand held administration of radiopharmaceuticals by injection. M so doing, occupational dose rates ) will be immediately reduced and the goal of ALARA as specified in 10 CFR 20.1101 (b) will be furthered. One of your. primary duties is to establish regulations on the safe use of nuclear materials. Specifically requiring the use of the Angel Shield will immediately make the administration of radiopharmaceuticals by injection safer. I would be glad to give a personal demonstration on the use of the Angel Shield so you can see first hand how this device can safely and conveniently lower occupational dose rates. Please do not hesitate to contact me should you require additional Information. j l S er ly, { J ffrey . Angel 901 Hillcrest Drive Apt. 606 Hollywood, FI 33021 Home (954) 893-5497 Work (305) 654-5049 Beeper (305) 901-4003 e-mail: halos 600@aci.com 6

m L D RADIATION PROTECTION 0 N. The Ange Shield A Radioactive Substance Administrator Reduces Radiation Exposure Rates By:

1. Eliminating hand-held injections

2. Mechanizing the injection process

3. Completely shielding the syringe

4. Reducing missed injections

5. Allowing for remote administration Reduces Handlina Time

> Load syringe into administrator and never touch it fully loaded again. d!. > Administer radionuclide via the remote dispensing rod. > Flush radionuclide into the patient via sterile saline flush. gi[ > Patient IV is established prior to administration thereby reducing missed injections and multiple exposures, increases Radiation Protection f[ . > Administrator completely encapsulates syringe providing 360 of shielding, g > Syringe is surrounded by %" lead walls for unequaled radiation protection. m > Remote dispensing rod removes you from direct and immediate contact from the 4 source. 4 > IV extension tubing increases the distance between you and the source. Reliable and Durable > Aluminum outer casing ensures that lead inserts maintain their shape and protective capacity. > Precision craftsmanship makes the shield nearly indestructible. > Rigid pivoting stand provides for ease of use. Exclusive Distribution Through Pinestar Technology #1-800-682-2226 Patent Pe'ndins b

ANGEL SHIEL.D %? ,? Eliminates hand-beid injec- .gi$ TIM E - tions DISTANCE Eliminates missed injections SHIELDING Provides 360 degrees of shielding sc-. 'L O. A R ADIO ACTIVE St'HST ANCE AD\\lINISTR ATOR I. Remove shield from stand by

2. Remove cap from body of

3. Load spinge into body of turning screw counter clock-shield shield, attach your connector, wise. Shield titls out of stand.

carefully replace cap onto body ofshield.

4. Place shield into stand and

5. Start IV in patient and attach

6. To administer the secure by turning screw clock-to radiopharmaceutical, place the icog wise. Attach saline flush to end of the dispensing rod into the connector hole in the top of the shield, gently depress the rod until the dose is expelled, flush the dose into the patient with the saline solution.

PINESTAR TECHNOLOGY, INC. P.O. BOX 824 GREENVILLE. PA 16125 Phone:1-800-682-2226 Fax: 1 724-932-3176 Email: pti'd nauticom.. net w ww. pin esta r.com Patent ~ PeM!nr

\\ 4 - a G pgG. } f^ ~ e g;. The ANGEL SHIELD A Radioactise Substance Administrator Eliminates hand held injections Eliminates (nissed injections Provides 360 degrees of shiciding Safe, Effective, Affordable TIME DISTANCE SIIIELDING The Angel Shield is the newest and most effective radiation protection device on the market. The Angel Shield utilizes the fundamental radiation protection principles of time, distance and shielding and successfully incorporates them into a safe, easy to use, and affordable radioactive substance admin-istrator. The Angel Shl:Id is more than a new product,it's a revolutionary new concept and the way to inject rausoactive substances. It provides complete radiation protection by totally encapsulating the ra-dioactive syringe within the administrator. The entire injection process is mechanized thereby removing the technologist from direct and immediate contact with the radioactive substance. Reduced Handline Time i Load the syringe into the administrator and never touch it fully loaded again j e Administer the radionuclide into the patient via the sterile saline flush l Patient IV has been established prior to initiating administration thereby eliminating missed injec-e e tions and multiple exposures i i More Radiation Protection _ RadionucliJe is completely encapsulated within the administrator providing 360 degrees of protec-e tion { Remote dispensing rod remoses the technologist from direct and immediate contact with the e ) radionuclide. Reliable and Durable j Aluminum outer casing ensures that the lead inserts maintain their shape and protective capacities, e Precision craftsmanship makes the administrator virtually indestructible e Rigid stand provides for ease of use. e PIN ESTAR TECH NOLOGE INC. P.O. I1ON 824 GRI-:1:Wil.11 PA 16125 Phone: 1-800-6S2-2226 Fas: 1 24 932-31 6 l'111 ail: 11tI u nautteon).tlet n u n.ln tles ta r.co n) Eggnt Pendil.t i

\\ NEW PRODUCT RADIATION PROTECTION DEVICE i LOWER OCCUPATIONAL DOSE RATES ARE REASONABLY ACHIEVABLE TRADITIONAL SYRINGE RAD'IATION l SHIELDS ARE OBSOLETE i 1 UNEQUALED RADIATION PROTECTION 4

..-,,.-.,m j M [7590-01-P] NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 [ Docket No. PRM-35-15]. - Jeffery C. Angel; Receipt of Petition for Rulemaking L 9 ~ AGENCY: Nuclear Regulatory Commission. i l . ACTION:: Petition for rulemaking; Notice of receipt. j

SUMMARY

The Nuclear Regulatory Commission (NRC) has received and requests public comment on a petition for rulemaking filed by Jeffery C. Angel. The petition has been docketed L 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. , DATE: Submit comments by (75 days following publication in the Federal Reaister). 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. I g.'

1 F-1 ! J^ 2 l-Deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and l 4i15 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 f l http1/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 l Toll free: 1-800-368 5642 or E-mail: DLM10NRC. GOV. j 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.. 4

..,.c....n.,...m-p.- 3; 3" The NRC's regulations goveming the medical use of byproduct material appear in 10 CFR Part 35. ' Paragraph (c) of 9 35.60 requires that an individual use a syringe radiation shield when administering a radiopharmaceutical by injection unless the use of the shield is

1 contraindicated for that patient or human research subject.

l Discussion - ~ The petitioner states that the current practic'e of placing the radiopharmaceuticalinto a syringe radiation. shield and delivering a hand-held injection places the person administering the ' substance in direct and immediate contact with the radioapharmaceutical. The petitioner contends that this practice results in the unnecessary exposure of this individual to radiation. l 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 .fdesigns violate the fundamental radiation principles of tims, shielding, and distance. The ~ . petitioner states that syringe radiation shields provide inadequate radiation protection because -- l i -1..The'y 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.

t-l ' zThe petitioner refers to the provisions of 10 CFR 20.1101 (b) that require licensees to g 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). x

4 4 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.

1 The petitioner explains that the Angel Shleid uses %-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 criticalimportance 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

l I .5 I that prohibiting the hand-held administration of radiopharmaceuticals by injection and requiring ' the use of the Angel Shie!d makes the administration of radiopharmaceuticals safer and furthers the goals of ALARA'by reducing occupational dose rates. The Petitioner Tne 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. 6 Dated at Rockville, Maryland, this 17 day of August,1999. { l ~ For the Nuclear Regulatory. Commission. 1 Andrew L. Bates, Acting Secretary of the Commission.

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