Information Notice 1994-09, Release of Patients with Residual Radioactivity from Medical Treatment & Control of Areas Due to Presence of Patients Containing Radioactivity Following Implementation of Revised 10 CFR Part 20

Release of Patients with Residual Radioactivity from Medical Treatment & Control of Areas Due to Presence of Patients Containing Radioactivity Following Implementation of Revised 10 CFR Part 20

ML031070027
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	02/03/1994
From:	Paperiello C NRC/NMSS/IMNS
To:
References
IN-94-009, NUDOCS 9402010228
Download: ML031070027 (7)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 February 3, 1994 NRC INFORMATION NOTICE NO. 94-09: RELEASE OF PATIENTS WITH RESIDUAL

RADIOACTIVITY FROM MEDICAL TREATMENT AND

CONTROL OF AREAS DUE TO PRESENCE OF

PATIENTS CONTAINING RADIOACTIVITY FOLLOWING

IMPLEMENTATION OF REVISED 10 CFR PART 20

Addressees

All U.S. Nuclear Regulatory Commission medical licensees.

Puroose

NRC is issuing this information notice to notify addressees of the

Commission's intent for release of patients pursuant to 10 CFR 35.75. It is

expected that licensees will review this information for applicability to

their operations and distribute it to appropriate staff. The information

contained in this notice does not include new NRC requirements; therefore, no

specific action nor written response is required.

Description of Circumstances

NRC's current patient release criteria, adopted in 1986, are contained in 10 CFR 35.75, "Release of patients containing radiopharmaceuticals or permanent

implants." Specifically, this section states:

(a) A licensee may not authorize release from confinement for medical

care any patient administered a radiopharmaceutical until either:

(1) The measured dose rate from the patient is less than 5 millirems (mrem) per hour at a distance of one meter; or

(2) The activity in the patient is less than 30 millicuries

(mCi).

(b) A licensee may not authorize the release from confinement for

medical care of any patient administered a permanent implant until

the measured dose rate is less than 5 millirems per hour at a

distance of one meter.

In the discussion of the proposed 10 CFR 35.75 in 1985, the Commission stated

that the proposed limits (30 millicuries (mCi) of activity or 6 milliroentgens

per hour dose rate at 1 meter, based on the exposure rate from 30 mCi iodine-

131), provided an "... adequate measure of safety for the general public, and

that further reductions in public exposure are not reasonably achievable

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IN 94-09 February 3, 1994 considering the cost and potential for detrimental effect from an

unnecessarily long hospital confinement.' Subsequently, the 1986 Statements

of Consideration for the revision to 10 CFR Part 35 discuss that the release

criteria, specified in 10 CFR 35.75 (30 mCi of residual activity or

5 millirems per hour (mrem/hr) dose rate at 1 meter) are based, in part, on

the considerations addressed in NCRP Report No. 37, 'Precautions in the

Management of Patients who Have Received Therapeutic Amounts of

Radionuclides.' Again, the Commission reiterated that the release limit

provided an adequate measure of public health and safety.

On May 21, 1991, NRC published a final rule (56 FR 23360) that amended 10 CFR

Part 20, Standards for Protection Against Radiation." Licensees are required

to implement the revised Part 20 by January 1, 1994. 10 CFR 20.1301(a)

requires, in part, that a licensee conduct operations so that: 1) the total

effective dose equivalent to any individual member of the public from licensed

activities does not exceed 1 millisievert (mSv) (0.1 rem) in a year; and

2) the dose in any unrestricted area from external sources does not exceed

0.02 mSv (0.002 rem) in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />. There has been some concern, in the

medical community, that a licensee, assuming compliance with 10 CFR 35.75 and

other applicable Part 35 requirements', in releasing, from confinement, a

patient containing byproduct material, could be in violation of the revised

Part 20, if the dose limits specified in 10 CFR 20.1301(a) are exceeded as a

result of radiation emitted from a patient undergoing a medical procedure.

Discussion

The adoption of 10 CFR 35.75 in 1986 was based on an independent NRC public

health and safety judgment specific to patient release, and was neither tied

to, nor designed to implement, the more general Part 20 dose limits that were

later revised in 1990. When Part 20 was revised, there was no discussion in

the "Statements of Consideration" on whether or how the provisions of 10 CFR

20.1301 would apply to the release of patients. Since a general and a

specific regulation of the Commission both address the same subject, the

staff, in consultation with the Commission, has taken an interim position that

the more specific regulation prevails in this case, pending action to formally

resolve the issue in response to pending rulemaking petitions.

Therefore, licensees should continue past practices regarding radiation

exposure to individual members of the public from radioactive materials

administered to patients, whether inpatients or outpatients. The provisions

of 10 CFR 20.1301(a) should not be applied to radiation received by a member

of the general public from patients released from confinement in accordance

with 10 CFR 35.75 and other applicable requirements in Part 35. Furthermore, if a patient is not required to be confined, pursuant to 10 CFR 35.75, licensees are not required to limit the radiation dose to members of the

public (e.g., visitor in a waiting room) from a patient to 0.02 mSv (2 mrem)

in any one hour. Patient waiting rooms or hospital rooms need only be

controlled for those patients not meeting the release criteria in 10 CFR

35.75.

(

<)IN 94-09

- February 3, 1994 This information notice requires no specific action nor written response. If

you have any questions about the information in this notice, please contact

one of the technical contacts listed below or the appropriate regional office.

Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material

Safety and Safeguards

Technical contacts: Patricia K. Holahan, NMSS

(301) 504-2694 Catherine T. Haney, NMSS

(301) 504-2628 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

At t hment 1 IN 94-09 February 3, 1994 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

94-07 Solubility Criteria for 01/28/94 All byproduct material and

Liquid Effluent Releases fuel cycle licensees with

to Sanitary Sewerage under the exception of licensees

the Revised 10 CFR Part 20 authorized solely for

sealed sources.93-100 Reporting Requirements 12/22/93 All U.S. Nuclear Regulatory

for Bankruptcy Commission licensees.

93-80 Implementation of the 10/08/93 All byproduct, source, and

Revised 10 CFR Part 20 special nuclear material

licensees.

93-77 Human Errors that Result 10/04/93 All nuclear fuel cycle

in Inadvertent Transfers licensees.

of Special Nuclear Material

at Fuel Cycle Facilities

93-69 Radiography Events at 09/02/93 All holders of OLs or CPs

Operating Power Reactors for nuclear power reactors

and all radiography

licensees.

93-60 Reporting Fuel Cycle and 08/04/93 All fuel cycle and materials

Materials Events to the licensees.

NRC Operations Center

93-50 Extended Storage of 07/08/93 All licensees authorized

Sealed Sources to possess sealed sources.

93-36 Notifications, Reports, 05/07/93 All U.S. Nuclear Regulatory

and Records of Misadmin- Commission medical

istrations licensees.

93-31 Training of Nurses 04/13/93 All U.S. Nuclear Regulatory

Responsible for the Commission medical

Care of Patients with licensees.

Brachytherapy Implants

I

At 'chment 2 IN 94-09 February 3, 1994 Page 1 of I

LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

94-08 Potential for Surveil- 02/01/94 All holders of OLs or CPs

lance Testing to Fail for nuclear power reactors.

to Detect an Inoperable

Main Steam Isolation Valve

93-26, Grease Solidification 01/31/94 All holders of OLs or CPs

Supp. I Causes Molded-Case for nuclear power reactors.

Circuit Breaker Failure

to Close

94-07 Solubility Criteria for 01/28/94 All byproduct material and

Liquid Effluent Releases fuel cycle licensees with

to Sanitary Sewerage Under the exception of licensees

the Revised 10 CFR Part 20 authorized solely for

sealed sources.

94-06 Potential Failure of 01/28/94 All holders of OLs or CPs

Long-Term Emergency for boiling water reactors.

Nitrogen Supply for the

Automatic Depressurization

System Valves

93-85, Problems with X-Relays 01/20/94 All holders of OLs or CPs

Rev. 1 in DB- and DHP-Type for nuclear power reactors.

Circuit Breakers Manu- factured by Westinghouse

94-05 Potential Failure of 01/19/94 All holders of OLs or CPs

Steam Generator Tubes for pressurized water

with Kinetically Welded reactors (PWRs).

Sleeves

94-04 Digital Integrated 01/14/94 All NRC licensees except

Circuit Sockets with licensed operators.

Intermittent Contact

94-03 Deficiencies Identified 01/11/94 All holders of OLs or CPs

during Service Water System for nuclear power reactors.

Operational Performance

Inspections

OL - Operating License

CP - Construction Permit

IN 94-09 February 3, 1994 This information notice requires no specific action nor written response. If

you have any questions about the information in this notice, please contact

one of the technical contacts listed below or the appropriate regional office.

Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material

Safety and Safeguards

Technical contacts: Patricia K. Holahan, NMSS

(301) 504-2694 Catherine T. Haney, NMSS

(301) 504-2628 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

EKraus, TechEd

11/17/93 *See attached concurrence

OFC IMAB* I 1MAB* I IMAB* lIMOB* Il

NAME PKHolahan LWCamper l JEGlenn FCCombs

DATE 12/15/93 12/15/93 _ 12/15/93 1 12/15/93 OFC OE* lOGC* I DD/IMNSj

j ljIIE

NAME PSantiago STreby EWBrach Cjf ello l

DATE 12/20/93 12/17/93 12/20/93 12/20/93 DOCUMENT NAME: 94-09.IN

The Commissioners 5 RECOMMENDATION:

That the Commission: Note that the staff will issue the enclosed

Information Notice within 10 working days f the date

of this paper, unless directed otherwise y the

Commission.

James M. Taylor

Executive Direc or

for Operati s

Enclosures:

1. Draft Information Notice

2 OGC memo dtd 10/22/93 cc: 0

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NRC File Center IMAB r/f IMNS Centr F e CPoland CHaney

MSS DirOff r/f WReamer PRathbun DEDS CGJones

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TechEd

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DATE 1 i93 12/[1L/93 12/___93 _ 12/4

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DATE /1I93

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