ML20030D789

Responds to Re Shipments of Co-60 Originating in Canada & Passing Through State of Oh.Rept of Inquiry Discussing Types,Quantities & Frequencies of Shipments & Regulatory Jurisdictions Involved Encl

ML20030D789
Person / Time
Site:	07100454
Issue date:	09/04/1981
From:	Palladino J NRC COMMISSION (OCM)
To:	Rhodes J OHIO, STATE OF
Shared Package
ML20030D790	List: ML20030D789 ML20030D794 ML20030D796
References
NUDOCS 8109160274
Download: ML20030D789 (7)

Text

f Cstu UNITED STATES

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g NUCLEAR REGULATORY COMMISSION n

j wAsmNorca, o. c. 20sss

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September 4,1981 OM U YI / f CHAMMAN 2 mI

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SEP 101981 *,

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The Honorable James A. Rhodes 2

t' Governor of Ohio

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Columbus, Ohio 43215 4

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Dear Governor Rhodes:

This is in response to your letter of June 26, 1981 regarding the shipments of cobalt-60 originating in Canada and passing through the State of Ohio.

Although we understand your concerns, on the basis of known facts and availa' ole information we see no immediate concern for the safety of citizens in your State nor an immediate need to initiate an investigation of the carriers of the cobalt-60 shipments.

I have enclosed a copy of a Report of Inquiry discussing the types, qualtities, and frequencies of shipments of cobalt-60 in Ohio, the packaging and shipping controls exercised, and the regulatory jurisdictions involved. We found that these shipments were all related to health care industries.

In your letter you expressed a desire for participation by the State of Ohio in an investigation of cobalt-60 shipments.

Since we see no

-immediate need to initiate an investigation, we have not requested the participation of your State. However, we would, of course, assist you and the U. S. Department of Transportation (DOT) in any study dealing with the transportation of radioactive materials in Ohio, should such a study be initiated. Also, the Federal Government has a program to improve state and local government participation in inspecting shipments of radioactive material.

Under this State Surveillance Program, individual state and local governments contract with DOT to inspect packages of radioactive material, the vehicles in which they are shipped, and the facilities in which they are handled. Should you wish more information on this program, the DOT contact for the State Surveillance Program is L. D. Santman, Director, Materials Transportation Bureau, U. S. Department of Transportation, Washington, D. C.

20590.

Transportation of radioactive material is regulated at the Federal level by both the U. S. Nuclear Regulatory Commission and the 00T. These two agencies have partitioned their regulatory responsibility in a Memorandum of Understanding, a copy of which is enclosed.

In general, D0T is responsible for regulating safety in carriage which includes marking and i

labeling of packages, vehicle placarding, loading, storage, monitoring, 8109160274 81090'4 PDR COMMS NRCC CORRESPONDENCE PDR

0 The Honorable James A. Rhodes 2

accident reporting and approval of packages used to transport small quantities of radioactive materials.

NRC is primarily responsible for regulating the packages used to transport larger quantities of radio-active materials and for transportation safeguards (security).

DOT reviews and endorres the safety certification of the packages (container:) used in shipments of nuclear materials imported from

-competent foreign authorities.

Should foreign-made packages be used for shipments solely within the United States, the NRC is then involved with the approval and certification of the package design prior to its use.

I trust the enclosed information has satisfactorily addressed your concerns about the shipments of cobalt-60 through the State of Ohio.

Should you have any further questions or specific concerns after reading the enclosed information, we would be pleased to respond to them.

If you wish, members of the NRC staff can meet with 0 hic officials and further explain the NRC rules and procedures relating to the transportation of radioactive materials.

Sincerely, m W &c Nunzio J. P adino

Enclosures:

1.

Report of Inquiry 2.

Memorandum of Understanding cc: The Honorable William G. Milliken Governor of Michigan I

A

Report of Inquiry July 24, 1981

SUBJECT:

SHIPMENTS OF COBALT-60 IN OHIO 1.

Purpose of Inquiry:

An inquiry was made to gather more information about the shipments of cobalt-60, and to summarize the regulatory requirements

~

applicable to those shipments.

An accident that occurred in southeastern Ohio in June 1981 was also reviewed.

2.

Atomic Energy of Canada, Ltd. (AECL) (the shipper)

This company makes about 300 import and export shipments per year (into and from the U.S.).

Shipments consist mainly of cobalt-60 encapsulated sources ranging from 10,000 to 15,000 curies.

AECL has both NRC and Agreement State licenses for their operations.

The company's U.S. address for the NRC license is 420 Babylon Road, Horsham, Pennsylvania.

For import shipments (into the U.S.) Canadian packaging (containers) is used. The safety review of these containers is performed by the Atomic Energy Control Board (AECB) of Canada. These reviews by the AECB are revalidated by the U.S. Department of Transportation (DOT). This is explained further in the Memorandum of Understanding between NRC and DOT (Attachment 1).

The receivers of these import shipments of nuclear materials must be a licensee of either NRC or an Agreement State.

For expcrt shipments, an NRC licensee may use packages (containers) for radioactive material which have a foreign certification revalidated by DOT.

This is covered by NRC regulations in Title 10, Code of Federal Regulations 10 CFR Part 71, Section 71.12(c).

Under these same regulations 71.12(c) the licensee must have an NRC-ap-proved quality assurance program for radioactive material packages. is a copy of AECL's Quality Assurance Program for delivery of licensed material to a carrier for transport, and NRC's certificate of approval of that program, approval number 0454, dated May 28, 1981.

The carriers (trucking companies, aircraft, etc.) are regulated by the DOT. In 1980, AECL made seven shipments of cobalt-60 to and through the State of Chic; three shipments within Ohio and four through Ohio with a destination il the State of Nebrasku.

The shipments within Ohio consisted of a total quantity of 105,000 curies of cobalt-60 encapsulated sources; the shipments through the State consisted of a total of 1,280,000 curies of cobalt-60 encapsulated sources.

The shipments within Ohio were to an NRC licensee, Advanced Medical i

Systems, Inc., in Cleveland.

The source, as explained later in the discussion of this li. cense, were replacement sources for medical tele-therapy machinec.

I k.

. Enclosure 1 The shipments through Ohio were destined for a licensee of the State of Nebraska, an Agreement State.

The encapsulated cobalt-60 sources were replacement sources for an irradiator facility used for sterilization of medical products, such as sutures, needles, etc.

All these shipments were related to " health care industries."

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The carrier of these shipments was Glengarry Consolidated, a Canadian Company.

The DOT Bureau of Motor Safety, the agency with inspection and enforcement jurisdiction over motor carriers, reports that there is no adverse infor-mation on the Canadian carrier, Glengarry Consolidated.

They have not done a complete facility audit of the company, but some of the company's carriers have been inspected during transit.

It is not known if any of the seven shipments of cobalt-60 to and through Ohio were inspected.

DOT searched its file of " Hazardous Materiais Incident Reports" and found no reports on Glengarry Consolidated and no reports connected with AECL for the past 5 years.

Prior to that, there were four incidents reported when AECL was the shipper, (three in 1974 and one in 1975.) In two of these shipments, the Tri-State Motor Company was the carrier, Roadway Express was the carrier in another, and American Airlines was the carrier in the fourth case.

In the Tri-State situations that occurred in February 1974, some spots of contamination were found in the truck but the consignment was free of con-tamination; in January 1975, some isolated spots of contamination and some contaminated gloves were found on the floor of the vehicle.

In the Roadway Express incident, a shjpment of a container with a cobalt-60 source was enclosed in a wooden overpack and the wooden overpack sustained some damage in transit.

The primary container remained intact and the source was not affected.

In the American~ Airlines report, the source container was accidentally dropped from a height of about 10 feet onto an apron at the air terminal.

The container remained intact and the radio-active source was not affected.

In these incidents, AECL could be fcund at fault only in the Tri-State situations, and then only perhaps for not checking and surveying the trucks before they loaded the shipment.

The other incidents' occurred during transit and outside the control of the shipper, AECL.

3.

NRC Licensees in the State of Ohio (the receiver in Ohio)

The NRC licensee in Ohio that uses substantial quantities of cobalt-60 in its operation is Advanced Medical Systems, Inc. (formerly the Picker Corporation), Cleveland, Ohio.

The NRC license number which expires November 30, 1984 is 34-19080-01.

The operations under this license involve the changeout of cobalt-60 sealed sources in medical teletherapy machines.

The supplier of these scurces is Atomic Energy of Canada, Ltd. (AECL), in Ontario, Canada.

The i

.. Enclosure 1 licensee receives a shipment from AECL about once each 3 months.

The nominal total' curie quantity of a single shipment is about 50,000 curies, or about 200,000 curies per year.

The shipments are made in containen's certified by the Canadian Atomic Energy Control Board.

Under the regulations, the Canadian certification of a container safety design is revalidated by the DOT if the container is used for shipments into the United States.

The primary documents included with the Canadian shipinents include:

(1) emergency instructions for the driver, (2) complete drawings of the container (s) with instructions in both English and French, (3) certifi-cates of radioactive leak-testing of the sources, and (4) reports of radiatior. measurements at the surface of 1 meter from the container.

4.

Transportation Incident in Southeastern Ohio The only recent transportation accident involving nuclear materials that we are aware of occurred, according to reports, on June 9, 1981.

The following information was taken from our Region III (Chicago) office daily report for June 11, 1981.

The regional office received the information from the Ohio Department of Health on June 10, 1981. The NRC licensee involved was Shellwell Services, Inc., Hebron, Ohio, license number 34-10445-01. The licensee's vehicle carrying two sealed sources, turned over after hitting a bridge abutment on Route 30 near Massillon, Ohio, at 11:30 p.m. on June 9,1981.

A 2.8-curie americium-241-beryllium well-logging source remained in its shielded container; a 125 millicurie cesium-137 source remained in its logging tool but the tool came out of its lead shield sleeve.

The driver kept personnel away from the vehicle.

A licensee representa-tive returned the tool to its lead shield about 30 minutes after the accident and the sources were returned to the licensee's facility.

The licensee reported a radiation level of 2 millirem / hour at 10 feet from the unshielded tool.

A medical examination showed both vehicle occupants were uninjured.

However, the incident data was pursued by local media.

Attachments:

1.

Memorandum of Understanding 2.

Quality Assurance Program Approval for Radioactive Material Packages s

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MEMORANDA OF UNDERSTANDING l Expl:sives Act (la USC. 831-435), the

1. Structur:;l mat:ruls of fabricator::

Dangerous Cargo Act (R.S. 4472. as

2. Cosure dsvices:

amer.ded. 44 USC.170). Title VI and

3. Structural integnty; so2fh)of the Federal Aviation Act of

4. Criticality controh

., 1954 (4e U.S.C.1421-1430 and 1472(hl).

5. Containment of radioactive the Department of Transportauon Act matenah 1

(49 USC.1615), and the Hazardous

6. Shielding:

Materials Transportatica Act (49 USC.

• Geraration ofinternal pressure; 1801-1812),is required to regulate safety

8. Internal corummmataan of packagn in the transportation of hazardous

9. Protec:fon against internal matertala, lac!uding radioactive overheeting; and materials.

10. Quality assurance of packaging The Nurlear Regulatory Commission dasign. fabncataan. testing.

(NRC). under the Atomic Energy Act of muintenance, and use.

1954. as amended (42 USC. Chapter 231

11. Adoption of Safety Starcards and and Section 201 of the Energy Reorganization Act of 1974, as amended

@/arions i

(42 U.S.C. 5441). is authorized to license A.N DOT will adopt regulations and regulate the receipt. possession, use.

imposing on shippers and carners as m sesso hhha**s 7/2/7s and transfer of "by product material."

subject to its Junedicuan those

" source materisl." and "special nuclear standards developed by the DOT and DEPARTMENT OF TRANSPORTATION thaterial" (as defmed in 42 U.S.C. 2014)-

the NRC pursuant to Section 1 of this N NRC autbonty to license air Memorandum of Understanding and any Nuoteer Reguinaory e"h shipment of platommn is further additional requirements necessary to governed by Pub. L 94-79.

protect the public health and safety.The Transponahn W M For the purpose of developing.

DOT will requiro NRC approval of l

M*'* *

"* 'I establishias.and implementing designs of packages for shipment of coreans and comprehensive fissile materials and other radioactive i

The roles of the Department of regulations and requiramentdor the meterials in quantities exceeding Type Transparention and the Nuclear safe transportation of radioactive A haits (axcept LSA materials) by all 1

Regulatory Commimaann la the regulation materials. and avoiding duplicatsoe of persons subject to the jurtsdiction of the cf the sransportation of radiondive effort, the DCYr and the NRC agree.

DOT The DOT willissue complete and matar als were described in a subject to their respec:ive statutory comprehensive Federal regulations for memorandum of underttanding signed authoritism. as follows. Terms used in the packagmg and transportation of all on June a.197s N prenant this agreeansat are de6aad in 49 CFR radioactive materials as a part ofits memorandam supenedes a sen Parts too-lee and10 CFR part 71.

overalllaady of Federal regula ; ins (43 CFR Parts 100-199) for the packaging agrweent betwwe se AtWnergy I. Develepment 87Sa.fesyStandards and transportation of all hazardous Commission and the Department of Transportation. A tant of the A.The DCYr (la consultation with the materials.

mennorandes is set forth below.

NRC) will develop safety staminds for B.The NRC will adopt packaging the classification of radioactive standards for fisaile materials and for j.

"* M " M8 materiale: for the design specifications quantities of other radioactive matenais Abstract. His agreement delineates and performance requirements of (other than 1.SA raatanals) axceeding the respective responsibilities of the pacxages for quantities of radioactive Type A limits and will adopt regulations Department of Transportation (DOT) matenals (other than fissile materials) imposing on its licansees administrative.

i and the Nuclea:Regulato /'icaiselos not exceeding Type A limits and for low procedurril. and technical requimments j

(NRC) for the regulation of safety in specific arrivity (I.SA) radioactive necessary to protect the public health transportation of radioactive materials.*

materials; for the external radiation and safety and to assure the common It supersedes the existing agrunnent fields.labeting. and marking of all defense and security.

executed on Mar.h :2.1973. between radioactive materials packages and C.N NRC wiis adopt procedures.

the DOrand the Atomic Energy

• vehicles: for the mechanical conditions.

standards, and criteria for approval of l'

Commission. Generally, the DOT is construction requirements and tie.down package designs and for approval of ruponsible for regulating safety in requirements of carrier equipment: for special transport controls proposed by transportation of all hazardous the qualifications of carrier personnel.

the applicant for a given package design.

matenals, tam = radioactive for the procedu:es for loading.

The NRC will require its licensees to l

materials, and the NRC la responsible unloading, handling. and storage in comply with the DOT regulations when for regulating safety in receipt, transit: for any special transport those persons are not otherwise subject I

possession, una. and transfer of controls (excluding safeguartis) to the DCyr regulations. '

I byproducts, source. and special nuclear necessary for adietion safety during Ill. Pack #8' R' materiale.N NRC reviews and carriage; and for all other safety approvas or denies approval of packege requirements except those specified in A.The DOT will submit to the NRC designs for Snaile materials and for the next paragraph.

for review the following package other redinactive materials (other than B.The NRC (in consultation with the designs:

low specifsc activity materials)in DOT) will develop safety standards for

1. Specification containers. Approval quantities exceeding Type A limits, as design and performance of packages for by the NRC of package designs for ddined in 10 CFR Part 71.

fissde materials and for nuantities of fissile mateials and for radioactive Asrsement between the DOTand tA, other radioactive materiant. (other than materials (other than LSA materials) m

(

NAC. N Departrnent of Transportation LSA materials) exceeding Type A limits quantities exceeding Type A limits wil!

(DOT). under the Transportation of in the following areas:

be obtained before publication of such

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MEMORANDA OF UNDERSTANDING d:sigrs m the DOT reguhti:ns.

encoutase thy Ag-eemint Stat:s 8 and Vll Exchon#2 ofInformation

2. Packages with foreign cernficanon, tne DOT wul encourage the non.

A. Prior to issuance of any regulations Approval by the NRC will be obtamed Agreement States to impose incident by either the DOT or the NRC involymg before revalidation of the foreign reportng requirements on shippers and transportation of rad cactiva matenals,

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certficates required in the DOT receivers subject to the State

• each agency will advise and consch regulations for packass shipped Junediction.

bItween origtas and destinations within C. In all accidents, incidents, and with the other to avoid possible con!he*'

the United States. except for import and instances of actual or suspected leam, age in regulatons and to assure that (1) the esport shipments. Approval by the NRC involving packages of radioact2ve regulations will afford adequate is not requtred if a package is used matenal regulated by the NRC, the NRC protection of the health and safety of the solely for export or import or if a will normany be the lead agency frir public; (2) the effect of these regulauens will not be ini nical to the common package is authortzed by the DOT

, invesugacng the occurrence and defense and security of the United r:tulanons solely for transportauon prepanng the report of the investigation.

States: and (3) the regulations are in the through or over the United States The DOT may either participate. as p,iblic interest.

• between ongms and destinsbons a :propriata, in the investiganon with the B. The DOT and be NRC will outside the Untted !tates. the DOT has NRC as the lead agency or conduct a i

exchange information. consuh and the responsibility for exercising separate invesugation. Subsequent to discronon as to whether it requests NR, each invesugation mvolymg radioactive ass st each o6er & 6e m d review of such packages, matenal regulated by the NRC, the NRC gett 8pecia3 umpetence in se P '

3. Any package for which NRC and the DOT will lotatly defi 7 he scope au ns dur s.

cvaluanon is warranted in DOT opinion, of the enforcement actions to be taken B. The NRC wt!! evaluate packa ge by each agency to assure that shippers agency will make available to the other designs for flasile materials and for and carners are subject to concurrent subject to security requirements and other radioactive materials (other than and equivalent enforcement actions but statutory provisions affectmg the release Type A limits and will tites exceeding not unduly subject to duplicate of information, summaries of inspection

!.SA matenals)in quan if satisfactory.

enforcement actions.

records, investigations of serious issue approvals therefor (vt: a license.

D. nis section V does not affect the acc dents. and other matters relatin8 to Certificate of Comliance, or other authonty of the National Transportatfon 887,ty in ge tran8ponah.on d package approval) directly to the person Safety Board, which is independent of radoacdu matenals.

requesting the approvnl.

the DOT and the NRC. to receive Vill Working Arrangements d i nstigste IV. Inspection and Enforcement The NRC and the DOT wiU designate g

n d s ch wiU d

appr priate staff representatives and VI NationalCompetent Authority will establish joint working ins e on d enforce tp within its jurisdiction to assure A. The DOT will be the national arrangemerits fr,om time to time fer the compliance with its requirementa. The competent authonty with respect to the purpose e adrninistering this NRC wid assist the DOT. as appropriate, administrative requirements set forth in Mem randum of Understanding.

In inspecting shippers of fissile matenals the regulations for the Safe Transport of IX. Effect and of other radioactive materials in Radioactve Matenals of the quantttles exceeding Type A limits.

International Atomic Energy Agency A. Nothing herem. 1,s intended to affect B.The DOT and the bRC will consult (IAEA). In issuing certificates of the statutory exempuen of shipments of e:ch other on the results of their competent authority for the United radioactive materials made by or undar respective inspections in the areas States under those regulanons. the DOT the direction or supervision of the where the results are related to the other will require for certain packages other Department of Energy or the Depertment agency's requirements, and each will than DOT specification containers an of Defense in accordance with the tie enforcement action as it deems NRC approvalin acesrdance with provisions of 18 U.S.C. 832(c).

appropriate within the limits of itsSection III.A of this Memorandum of B. nis agree. ment shall take effect authority.

Understanding. The NRC will provide to upon the signmg by authorized the national competent authonty (DOT) representamves of the respective V. Accidents ondlncidents technical support and advice pertaining agenciee, and shall supersede in its A.ne DOT willrequira of allca riers to the transportation of radioactive entirety the March 22.1973.

subject to its jurisdiction the notification meterials.

Memor=nrlum of Understanding and reporting to the DOT of accidents.

B. The DOT will act as the between the DOT and the Atomic incidents, and instances of actual or representative of the United States to Energy Commission.

suspected leakage involving radioactive the IAEA and other international groups C. Nothing in this Memdorandum of m:terialpackages if such an event on matters pertaining to the Understanding is intended to restnet the occurs in transa and the DOT will administrative and safety regulatory statutory authonty of either the DOT or promptly notify the NRC of such events.

aspects of transportation of radioactive the NRC.

B. The NRC will require ofits materials.The NRC will provide l

licensees the notification and reporting technical support and advice to the DOT Done et Washington. D.C in mplicate. thm sth day of Nne tors.

l to the NRC of accidents. incidents, ar l

'n this capacity.

instances of actual or suspected leakage For the United State, Departmer e of Tramporta tion.

involving radioactive material packages g.

, o, p.g.,,

if such an event occurs prior to rielivery 5 tn a

int an ni Ai/> s istictor. escorch andSpecial j

to a carner for transport Cr after parnant to Section m of the Atenuc F.ntsy Act of Programs A dministretion. Degrrment of delivery to a r*ceiver.ne NRC will isx, s. am,.6,d ande wbch the NRC has I'm/mrtation.

reimqmahed to soch States tae masonry or its rete.iory authonry over sourca, byproduct and

. For the Urnted States Nuclent Regulator) 8Pecal nuclear matenalin quanenes not sufficient annussson.

to form a cnucal mass.

losoph M. Hendrie.

Chairman Nuclear Regulotory Comnussion.

s a

FOR RADIOACTIVE MATERIAL PACKAGES

" y "'"

Pursu:rit to the At:mic Energy Act cf 1954,cs amended,the Energy Rcorganization Act of 1974, as amenced, and Title 10, Code of Federal Regulaties, Chapter 1, Part 7t, and iri rcliance on statements and representations heretofore made in item 5 by the person named in item 2,the Quality Assurance Program identified in item 5 is hereby approved. This approval is issued to satisfy the requirements of Section 71.51 of 10 CFR Part 71. This approval is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

2, N A M E

3. E X PIR ATION OAT E Atomic Energy of Canada, Ltd.

July 31, 1986 STnE ET ADORES $

P.O. Box 6300

( oocur ~uye R Ottawa ISTATE l ZIP CODE CIT v Canada i K2A3W3 71-0454 5, QU AblT Y ASSUR ANCE PROGR AM APPLICATION DATEtS)

May 25, 1981 S. CO NDITIONS A.

The shipping activities authorized by this ap, Pl are procurement, maintenance, repair, and use of packages for lu.ensed material in special fonn and encapsulated licensed material.

All other shipping activities (i.e., design, fabrication, assembly, testing, and modification) are satisfied for packages for which a foreign national competent authority certificate has been revalidated by the U.S.

Department of Transportation or shall be satisfied by obtaining certifications from package suppliers that these activities were conducted in accordance with an NRC-approved QA program.

It shall-remain the responsibility of the licensee-user that all transportation

(

activities meet the requirements of 10 CFR 571.51.

B.

Domestic shipments (shipments which originate and tcrminate within the United States) in packages for which a foreign national competent authority certificate has been revalidated by the U. S. Department of Transportation is not authorized.

C.

Activities conducted under applicable criteria of Appendix E of 10 CFR Part 71 to be executed with regard to transportation packages by July 15, 1981.

h yphMobTh lgf 1

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n Mw,)M k, FM[E U.S. NUCLEAR REGULATORY COMMISSION sicNATuesharles E. MacDonaHri7 Chief, Transportation Certification Branch lOATEgW2 c EEI Division of Fuel Cycle and Material Safety, NMSS U.W o.,.. _

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CommercialProducts Produits Commerciau.x TC1(613) 592-2790 P.O. Fox S300 CP.6300 6-Or.awa. Canada Onawa. Canada Telex.053-4162 K2A3W3 K2A 3W3 gg A

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981 May 25 d

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RA81-5-47

%m Mr. Charles E. MacDonal

Chief, y

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Transport Certification Branuit, G-g U.S. Nuclear Regula;;ory Commission, Washington, D.C'.

20555 fibbbb/Eh (Mailstop 396-55) b 4

UAY3 7Jggy> F

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E Dear Mr. MacDonald;

1. "ji' lov

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SUBJECT:

ATOMIC ENERGY OF CANADA LIMITED -

7 COMMERCIAL PRODUCTS cc QUALITY ASSURANCE PROGRAM FOR DELIVERY OF LICENSED MATERIAL TO A CARRIER FOR TRANSPORT

REFERENCE:

TITLE 10, CHAPTER 1, PART 71, CODE OF FEDERAL REGULATIONS In accordance with the requirements specified in para-graph 71.51 of 10 CFR 71, we are enclosing eight copies of the subject document for your review and approval.

The submission is in the form of a commitmert by the company to implement a QA program and it is based on the guideline (dated 27 March 1980, Revision 2) which you pro-vided to us during our meeting in'your offices on 15 May 1981.

The authorization "to transport licensed material or deliver licensed material to a carrier for transport" is urgently required by the company in order to avoid unnec-essary disruption of medically related services to U.S. A.

Licencees.

We trust that those services we provide to Licencees, which have been temporarily withdrawn, can be resumed immediately.

A reasona'le period of time is requested bleb056M 0" W yaca

for _ streamlifilng those activities which require our several U.S.A. Branch Offices to become fully -;,7 pliant with the program.

Yours sincerely, LT.

E.F. Ridout,

Manager, Regulatory Affairs, Quality Assurance Division.

EFR/EB

Enclosures:

Eight copies Quality Assurance Program e

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9 E

1913S