Information Notice 1989-74, Clarification of Transportation Requirements Applicable to Return of Spent Radiopharmacy Dosages from Users to Suppliers

Clarification of Transportation Requirements Applicable to Return of Spent Radiopharmacy Dosages from Users to Suppliers

ML031190094
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, 05000000, Zimmer, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	11/07/1989
From:	Burnett R NRC/NMSS/IMNS
To:
References
IN-89-074, NUDOCS 8911010053
Download: ML031190094 (9)

I/

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 November 7, 1989 NRC INFORMATION NOTICE NO. 89-74: CLARIFICATION OF TRANSPORTATION REQUIREMENTS

APPLICABLE TO RETURN OF SPENT RADIOPHARMACY

DOSAGES FROM USERS TO SUPPLIERS

Addressees

All manufacturers and distributors of radlopharmaceuticals for medical use, nuclear pharmacies, and medical licensees.

Purpose

This notice is provided to answer questions that frequently have arisen about

the regulatory requirements applicable to transportation of packages, containing

radioactive materials in the form of uspent' radiopharmacy dosages, from the user

back to the original supplier. Most of these questions have involved the

performance of shipper' responsibilities in such shipments.

It is expected that addressees will review the information here for applicabi- lity to their licensed activities, and consider actions, as appropriate, to

avoid problems in transport of such materials. However, suggestions contained

in this notice do not constitute any new U.S. Nuclear Regulatory Commission

(NRC) requirements, and no written response is required.

Background:

In the practice of nuclear medicine in the United States, many thousands of

routine shipments of diagnostic radiopharmaceuticals are made each day. Most

of these shipments are from the supplier" radiopharmacy, using private vehicles, to the licensee 'user," e.g., a hospital or physician. One major supplier, in

fact, transports between 1000 to 3000 shipments daily. As a part of the process, the user-licensee then returns such packages to the supplier, now containing

residual "spentm dosages, contaminated syringes, syringe shields, and multi- dose vials. The user places these materials in the original as-received

packagings, which are then picked up routinely by the supplier at the time

'fresh" packages are delivered to the users.

Discussion:

Pursuant to 10 CFR Section 71.5, NRC licensees who either transport licensed

radioactive material outside of their place of use, or deliver such material

to a carrier for transport, must comply with the applicable requirements of

the U.S. Department of Transportation (DOT) regulations 49 CFR Parts 170 to 179.

8911010053 Z

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IN 89-74 November 7, 1989 Radiopharmacy material shipments almost always involve situations

supplier is a "shipper" acting as a private carrier. The where the

"user" most often is transferring the residual spent-dosage hospital or physician

supplier, who then also assumes responsibility for performing packages to the

functions, as well as the carrier functions. the "shipper"

The questions/answers that follow are intended to clarify

the most frequently

asked questions which have arisen:

Q1. Who must act as the "shipper?"

A. Either party, e.g., the radiopharmacy (supplier) or its

may act as the shipper. DOT regulations provide no specificcustomer (user)

of a "shipper." The regulations do prescribe many requirements definition

to shippers, consignors, or the "...person who offers for applicable

DOT has taken the position that shipper functions actually transport."

by more than one party. This is, of course, the situation may be performed

radwaste "brokers." In that case, the waste generator may in the case of

of the shipper functions, such as filling, closing, and marking perform certain

and preparing a shipping paper. The generator then transfers the packages

to the broker, who receives and takes title to the packages, the shipment

manifest, and loads the package onto his vehicle for transport prepares a new

point or to a burial site. The broker, in effect, becomes to a collection

acting as a private carrier. Likewise, in radiopharmacy the shipper

shipment operations, the supplier functions as a shipper acting as a private

delivery of fresh packages to the user, as well as in thecarrier, in both the

spent-dosage packages from ITe user. In any case, all parties pickup of the

shippers assume liabilTEtyfor any violations that may occur. acting as

Q2. In the case of radiopharmacy spent-dosage shipments

from the user back to

the supplier, who is it preferable to have act as the shipper?

A. As stated previously, either party may act as the shipper, preferable that the supplier assume the responsibility. but it is usually

That is because

the supplier is generally more knowledgeable than the user about

requirements regulatory

for shippers and, likewise, is more apt

adequately equipped to meet those requirements. NRC than the user to be

strongly recommends

that the supplier and the user sign an agreement clearly

respective roles and responsibilities of each party, as delineating the

they relate to

shipper functions, thus eliminating any potential misunderstandings.

such a written agreement, the supplier may rely on the user With

agent in carrying out certain shipper functions. In such to act as his

will hold that supplier totally responsible for ensuring a case NRC

requirements are met. The agreement should be maintained that all shipper

furnished to an inspector upon request. In the absence onfile- and

of such a written

agreement, NRC will generally consider the end-user licensee

responsible for compliance with regulatory shipper requirements to be solelyi

returning radiopharmacX packages to the supplier. This when

is because the

end-user in this case is the point of origin of the shipment.

IN 89-74 November 7, 1989 Q3. What quality control measures would be appropriate on the part of the

supplier?

A. The return of spent radiopharmacy dosages as limited-quantity packages is

not technically subject to the formal shipper requirements for a quality

control program, as outlined in 49 CFR Section 173.475, as would be for

instance, the shipping of labeled Type A packages. However, if the sup- plier relies on the user to perform certain shipper functions on his

behalf, it is appropriate that the supplier establish procedures to ensure

compliance with shipping requirements for limited-quantity packages. Such

a program should Include: establishment and dissemination of packaging

procedures for the users to follow; provision for training of the Involved

user personnel; periodic audits by the supplier of the user's performance, to identify discrepancies; and provisions to effect corrective actions by

the user when discrepancies are observed. The specifics of this quality

control program should be covered in the written agreement between supplier

and end user. (See Question 2.)

Q4. Limited-quantity packages of return shipments of spent dosages sometimes

are placed within opaque plastic bags which may be either five-sided slip- covers or six-sided covers, providing almost total enclosure of the shipment.

This procedure often is used in lieu of performing contamination surveys to

assure compliance with 49 CFR Subsections 173.421(c) and 173.443(a). Please

comment on this?

A. Yes. In the first place, the two types of bags in question do not afford

the same quality of protection. The slipcover bags, since they do not

totally enclose the packaging, are not as effective as the six-sided

covers in preventing contamination. Although either of the bags nay

be a means of avoiding surface contamination, this is not the intended

use. The primary purpose of both types of bags is to display the limited- quantity statement required by 49 CFR Subsection 173.421-1 and to cover

the labels and marking that were opropriate when the package first came

into the user's facility. In order to ensure compliance with the limits

for surface contamination, as stated in Subsection 173.421(c), and certi- fied to by the statement on the bag, NRC strongly recommends that a

contamination survey be performed, although this is not mandatory for

limited-quantity packages. If contamination levels are found to exceed

the regulatory limits of Subsection 173.443(a), the user or the supplier

(if that supplier has assumed responsibility for the shipper functions)

will be found to be in violation of the section, regardless of whether

a contamination survey was made.

Q5. Some radiopharmaceuticals are returned to a supplier unused by the

the end user and not spent." These packages will usually be Type A,

since they exceed-the activity limits for a "limited quantity," as

specified'in 49 CFR Sections 173.421 to 173.423. Does this present

any complications?

'-

IN 89-74 November.7, 1989 A. Definitely. Different regulatory requirements are specified for packaging, labeling, marking, and shipping papers for Type A packages. If the end user

fails to inform the supplier that such packages are not limited-quantity, the packagings, labels, markings, and shipping papers may not be appropriate

to the material being returned. Whatever arrangements have been established

in the written agreement between the two parties, as to who performs the

specified shipper functions, should also hold for these situations. The

more formal requirements for a quality control program, as outlined in

49 CFR Section 173.475, would now apply for a package that contains more

than a limited quantity, e.g., a Type A package.

Q6. Packages containing residual materials and spent dosages usually contain

much less radioactivity than the original, Incoming Type A, labeled

packages. What are the principal requirements applicable to such

limited quantitites in order that they might qualify as "Radioactive

Material, limited quantity" packages?

A. The requirements of 49 CFR Section 173.421, Subsection 173.421-1, and Section 173.423 apply.

Briefly, these requirements state that:

1. The package must be strong, tight...";

2. The radiation level at any point on the external surface of the

package may not exceed 0.5 mrem/hr;

3. The radioactive content may not exceed the limits specified in

49 CFR Section 173.423;

4. Removable radioactive surface contamination on the exterior of

the packagl may not exceed the prescribed limits, e.g., 2,200

d/m/100 cm [49 CFR Subsection 173.443(a)];

5. The outside of the inner packaging, or if there is no inner packaging, the outside of the package itself must be marked "RADIOACTIVE;" and,

6. A notice, with prescribed wording per 49 CFR Subsection 173.421-1, must be included in,.on or identifiably with the package, certifying

that the package meets the requirements 7orlimited-quantity

radioactive materials.

Q7. I understand that distribution of nuclear medicine materials in the

United States is largely accomplished by a network of non-licensed

contract motor and air carriers who operate under exemptions issued

by DOT (DOT E-8308 for highway shipments and DOT E-7060 for air shipments).

Does this information notice relate to those shipments?

I

IN 89-74 November 7, 1989 A. No. The contract carriers involved as parties to those two exemptions

are license-exempt and therefore subject solely'to DOT Jurisdiction.

In effect, they are responsible for the carrier requirements of DOT

regulations, not the shipper requirements. They are also responsible

for maintenance of the raFa-tion-protection programs. §jspecied in

each exemption. In cases where 'spent' packages of MO - TC generators

are being returned by an end-user to a supplier using the contract carrier, the end-user is the originator of the return shipment and clearly is

responsible for the shipper functions.

Robert F. Burnett, Director

Division of Safeguards and

Transportation

Office of Nuclear Material Safety

and Safeguards

A. W. Grella, NMSS

(301) 492-3381 Attachment: List of Recently Issued NRC Information Notices

Attachment

IN 89-74 November 7, 1989 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

89-73 Potential Overpressurization 11/1/89 All holders of OLs

of Low Pressure Systems or CPs for nuclear

power reactors.

89-72 Failure of Licensed Senior 10/24/89 All holders of OLs

Operators to Classify or CPs for nuclear

Emergency Events Properly power reactors.

89-71 Diversion of the Residual 10/19/89 All holders of OLs

Heat Removal Pump Seal or CPs for nuclear

Cooling Water Flow During power reactors.

Recirculation Operation

Following a Loss-of- Coolant Accident

89-70 Possible Indications of 10/11/89 All holders of OLs

Misrepresented Vendor or CPs for nuclear

Products power reactors.

89-69 Loss of Thermal Margin 9/29/89 All holders of OLs

Caused by Channel Box or CPs for BWRS.

Bow

89-68 Evaluation of Instrument 9/25/89 All holders of OLs

Setpoints During or CPs for nuclear

Modifications power reactors.

89-67 Loss of Residual Heat 9/13/89 All holders of OLs

Removal Caused by or CPs for PWRs.

Accumulator Nitrogen

Injection

89-66 Qualification Life of 9/11/89 All holders of OLs

Solenoid Valves or CPs for nuclear

power reactors.

88-46, Licensee Report of 9/11/89 All holders of OLs

Supp. 4 Defective Refurbished or CPs for nuclear

Circuit Breakers power reactors.

OL = Operating License

CP e Construction Permit

IN 89-74 November 7, 1989 A. No. The contract carriers involved as parties to those two exemptions

are license-exempt and therefore subject solely to DOT jurisdiction.

In effect, they are responsible for the carrier requirements of DOT

regulations, not the shipper requirements. They are also responsible

for maintenance of the ra dation-protection programs, § speckied in

each exemption. Incases where 'spent packages of MO - TC generators

are being returned by an end-user to a supplier using the contract carrier, the end-user is the originator of the return shipment and clearly is

responsible for the shipper functions.

Robert F. Burnett, Director

Division of Safeguards and

Transportation

Office of Nuclear Material Safety

and Safeguards

A. W. Grella, NMSS

(301) 492-3381 Attachment: List of Recently Issued NRC Information Notices

Also reviewed by: Concurrence with minor Editorial changes:

EKraus, NMSS USDOT EEJakel, OGC STreby, OGC 10/24/89

Technical Editor MWangler, DOT

(2 times) 9/89 SGDB * SGDB * SGDB * IMNS * SGTR * SGTR

AGrella:ne PTing DKasun JGlenn GMcCorkle RBurnett

10/23/89 10/23/89 10/23/89 10/10/89 10/23/89 10/ /89

• SEE PREVIOUS CONCURRENCE

A. No. The contract carriers involved as parties to those two exemptions

are license-exempt and therefore subject solely to DOT jurisdiction.

In effect, they are responsible for the carrier requirements of DOT

regulations, not the shiPper requirements. They are also responsible

for maintenance of the raiat0ion-protection progrags, as9 pecified in each

exemption. In cases where 'spent" packages of MO - TC generators are

being returned by an end-user to a supplier using the contract carrier, the end-user is the originator of the return shipment and clearly is

responseiblefor the shipper functions.

Robert F. Burnett, Director

Division of Safeguards and

Transportation

Office of Nuclear Material Safety

and Safeguards

A. W. Grella. NMSS

(301) 492-3381 V

Attachment:

List of Recently Issued

NRC Information Notices

DISTRIBUTION:

SGDB r/f

AGrella

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Also reviewed by: Concurrence with minor Editorial changes:

EKraus, NMSS USDOT EEJakel, OGC STreby, OGC 10/24/89

Technical Editor MWangler, DOT

(2 times) 9/89 SGDB * SGDB * SGDB * IMNS * SGTR * SG

AGrella:ne PTing DKasun JGlenn GMcCorkle RB tt

10/23/89 10/23/89 10/23/89 10/10/89 10/23/89 10/5l/89

• SEE PREVIOUS CONCURRENCE

6

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A. No. The contract carriers involved as parties to those two exemptions

are license-exempt and therefore subject solely to DOT jurisdiction.

In effect, they are responsible for the carrier requirements of DOT

regulations, not the shipper requirements.Theiy are also responsible

for maintenance of the rada tion-erotection progrgs, asg§pecified in each

exemption. In cases where 'spent packages of MO - TC generators are

being returned by an end-user to a supplier, using the contract carrier, the end-user is the originator of the return shipment, and clearly is

responsiTElefor the shipper functions.

Robert F. Burnett, Director

Division of Safeguards and

Transportation

Office of Nuclear Material Safety

and Safeguards

A. W. Grella, NMSS

(301) 492-3381 Attachment:

List of Recently Issued

NRC Information Notices

DISTRIBUTION:

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