Models 3077/3077A Aerosol Neutralizers Instruction...

Models 3077/3077A Aerosol Neutralizers

Instruction Manual

P/N 1933077, Revision M September 2003

P a r t i c l e I n s t r u m e n t s

Product Overview 1

Models 3077/3077A Aerosol Neutralizers

Principle of Operation 2

Instruction Manual

Neutralizer Measure-ment, Handling, and Construction

3

Appendixes

Manual History

iv

The following is a manual history of the Model 3077 Series Aerosol Neutralizers (Part Number 1933077).

Revision Date Revision Date First Version January 1977

A July 1986 B May 1989 C October 1990 D November 1990 E September 1992 F November 1993 G January 1994

H October 1996 H1 July 1998 I November 1998 J March 2000 K July 2000 L October 2002 M September 2003

! Revision E includes a Safety section, updated NRC regulations, and a general reorganization of the manual contents.

! Revision F modifies a radiation measurement and dosage in Chapter 3.

! In revision G, TSI’s customer service number was changed.

! In revision H, TSI’s “Limitation of Warranty and Liability” on page iii was updated and a “One-Time Extension of License Ex-piration Date” letter from the United States Nuclear Regulatory Commission was added to Appendix B. In revision H1, TSI’s area code was changed from 612 to 651.

! In revision I the entire manual was updated as well as Appen-dix B, “NRC Documents and License.”

! In revision J the U.S. Nuclear Regulatory Commission Materials License was updated.

! In revision K, TSI’s Limitation of Warranty and Liability was up-dated.

! Revision L introduces new Model 3077A, U.S. Nuclear Regula-tory Commission Materials License 22-12602-03G Amendment 13 and includes 10 CFR Jan 2002 revisions. Measurements and Dosage sections are modified to reflect Model 3077A maxi-mum activity levels. TSI’s phone numbers were also updated.

! In revision M, specifications were updated in Appendix A, Table A-3 was added listing radiation levels.

v

Part Number 1933077 / Revision M / September 2003

Copyright ©TSI Incorporated / January 1977–2003 / All rights reserved.

Address TSI Incorporated / 500 Cardigan Road / Shoreview, MN 55126 / USA

Fax No. (651) 490-3824

E-mail Address [email protected]

Limitation of Warranty and Liability (effective July 2000)

Seller warrants the goods sold hereunder, under normal use and service as de-scribed in the operator's manual, shall be free from defects in workmanship and material for (12) months, or the length of time specified in the operator's manual, from the date of shipment to the customer. This warranty period is inclusive of any statutory warranty. This limited warranty is subject to the following exclusions:

a. Hot-wire or hot-film sensors used with research anemometers, and certain other components when indicated in specifications, are warranted for 90 days from the date of shipment.

b. Parts repaired or replaced as a result of repair services are warranted to be free from defects in workmanship and material, under normal use, for 90 days from the date of shipment.

c. Seller does not provide any warranty on finished goods manufactured by others or on any fuses, batteries or other consumable materials. Only the original manufacturer's warranty applies.

d. Unless specifically authorized in a separate writing by Seller, Seller makes no warranty with respect to, and shall have no liability in connection with, goods which are incorporated into other products or equipment, or which are modified by any person other than Seller.

The foregoing is IN LIEU OF all other warranties and is subject to the LIMITATIONS stated herein. NO OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR PARTICULAR PURPOSE OR MERCHANTABILITY IS MADE.

TO THE EXTENT PERMITTED BY LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE LIMIT OF SELLER'S LIABILITY FOR ANY AND ALL LOSSES, INJURIES, OR DAMAGES CONCERNING THE GOODS (INCLUDING CLAIMS BASED ON CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) SHALL BE THE RETURN OF GOODS TO SELLER AND THE REFUND OF THE PURCHASE PRICE, OR, AT THE OPTION OF SELLER, THE REPAIR OR REPLACEMENT OF THE GOODS. IN NO EVENT SHALL SELLER BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES. SELLER SHALL NOT BE RESPONSIBLE FOR INSTALLATION, DISMANTLING OR REINSTALLATION COSTS OR CHARGES. No Action, regardless of form, may be brought against Seller more than 12 months after a cause of action has accrued. The goods returned under war-ranty to Seller's factory shall be at Buyer's risk of loss, and will be returned, if at all, at Seller's risk of loss.

Buyer and all users are deemed to have accepted this LIMITATION OF WARRANTY AND LIABILITY, which contains the complete and exclusive limited warranty of Seller. This LIMITATION OF WARRANTY AND LIABILITY may not be amended, modi-fied or its terms waived, except by writing signed by an Officer of Seller.

Service Policy Knowing that inoperative or defective instruments are as detrimental to TSI as they are to our customers, our service policy is designed to give prompt attention to any problems. If any malfunction is discovered, please contact your nearest sales office or representative, or call TSI’s Customer Service department at 1-800-874-2811 (USA) or (651) 490-2811.

vi Model 3077/3077A Aerosol Neutralizers

Safety

vii

This section gives instructions to promote safe and proper handling of the Model 3077 Series Aerosol Neutralizers. The Model 3077 Series Aerosol Neutralizers contain a Krypton-85 source. Under normal circumstances, you will not come into con-tact with hazardous radiation. However, take these precautions when using the Neutralizer in a Model 3080 series Electrostatic Classifier or in another instrument:

❑ Corrosive materials can degrade materials that are a part of the Neutralizer. Do not operate the Classifier or other instrument with chemicals that corrode 303, 304, or 316 stainless steel, copper, silver solder or epoxy.

❑ Do not operate the Classifier or other instrument in tempera-tures above 50°C. Temperatures above 50°C may cause the Neutralizer to leak causing radioactive contamination.

❑ The Neutralizer has a half-life of 10.4 years. Keep all Neutralizer packing materials. After 10 years, TSI recommends you return the Neutralizer to the manufacturer and order a new Neutral-izer.

❑ Remove the Neutralizer using directions in Electrostatic Classi-fier manual (if applicable). Transport the Neutralizer using di-rections in this manual.

❑ Do not remove any parts from the Electrostatic Classifier unless you are specifically told to do so in the Classifier manual.

W A R N I N G The use of controls, adjustments, or procedures other than those specified in this manual may result in exposure to hazardous radiation.

I m p o r t a n t

Model 3077 Series Aerosol Neutralizers have been supplied to you under United States Nuclear Regulatory Commission General Li-cense No. 22-12602-03G issued to TSI Incorporated. You are a “general licensee” under the general license. Your purchase of the Aerosol Neutralizer has been reported to the NRC as required by the license. You are required to read and comply with the applicable regulations in the enclosed NRC regulations.

If you have any questions regarding your responsibilities under these regulations, contact the NRC office listed in 10 CFR 20, or TSI

viii Model 3077/3077A Aerosol Neutralizers

Inc. For your convenience, we have enclosed sections of 10 CFR in this manual. It is suggested that you contact your local government printing office to obtain a complete copy of 10 CFR, as it is updated yearly. These regulations include:

❑ Part 19—Notices, Instructions, and Reports to Workers: In-spection and Investigations

❑ Part 20—Standards for Protection Against Radiation

❑ Part 21—Reporting of Defects and Noncompliance

❑ Part 30—Rules of General Applicability to Domestic Licensing of Byproduct Material

❑ Part 31—General Domestic Licenses for Byproduct Material Also check any applicable local regulations and check to see if your state is an Agreement State. See TSI Incorporated NRC Supplemen-tary Information Manual 1930034 for additional information.

Model 3077/3077A Aerosol Neutralizers ix

Labels The Neutralizer has two exterior labels. Figure 1 shows the label at-tached to the cylindrical Neutralizer housing; Figure 2 shows the label attached to both ends of the housing.

RECEIPT, POSSESSION, USE AND TRANSFER OF THIS DEVICEARE SUBJECT TO A GENERAL LICENSE OR EQUIVALENT ANDREGULATIONS OF THE U.S. NRC OR AN AGREEMENT STATE

ABANDONMENT OR DISPOSAL PROHIBITED UNLESSTRANSFERRED TO PERSONS SPECIFICALLY LICENSED BY THENRC OR AN AGREEMENT STATE

DISMANTLING OR REPAIR OF THIS AEROSOL NEUTRALIZERSHALL BE PERFORMED ONLY BY PERSONS SPECIFICALLYLICENSED BY THE NRC OR AN AGREEMENT STATE

OPERATION PROHIBITED IF THERE IS INDICATION OF FAILUREOF OR DAMAGE TO THE SHIELDING OR SOURCE CONTAINMENT

LOSS, THEFT OR TRANSFER OF THIS DEVICE AND FAILURE OFOR DAMAGE TO THE SHIELDING OR THE SOURCE CONTAINMENTMUST BE REPORTED TO THE NRC OR AN AGREEMENT STATE –IMPORTANT–REMOVAL OF THIS LABEL PROHIBITED AND THIS LABEL SHALLBE MAINTAINED ON THE DEVICE IN A LEGIBLE CONDITION

DO NOT SUBJECT THIS DEVICE TO TEMPERATURES IN EXCESSOF 50°C

DO NOT EXPOSE THE INTERIOR OF THIS DEVICE TO GASES,AEROSOLS, OR LIQUIDS CORROSIVE TO TYPE 316 STAINLESSSTEELDO NOT DISCARD RETURN TO TSI

®

TSI IncorporatedST. PAUL, MINNESOTA U.S.A.

SERIAL NO.

MODEL NO.

DATE OFMEASUREMENT

MILLICURIES

MATERIAL CAUTION

RADIOACTIVEMATERIAL

Figure 1 Exterior Label

DO NOT OPEN THIS CONTAINEROR YOU WILL BE EXPOSED TO

UNACCEPTABLE RADIATION LEVELS!

Figure 2 Exterior Label

Contents

xi

Manual History.............................................................................iv Safety ..........................................................................................vii

Labels ..................................................................................... ix About This Manual .....................................................................xiii

Purpose..................................................................................xiii Organization ..........................................................................xiii Related Product Literature .....................................................xiv Getting Help...........................................................................xiv Reusing and Recycling ...........................................................xiv Submitting Comments ............................................................xv

Chapters 1 Product Overview ................................................................1-1 2 Principle of Operation .........................................................2-1 3 Neutralizer Measurement, Handling, and

Construction .......................................................................3-1 Radiation Measurements.......................................................3-1 Handling Information ............................................................3-1

Dosage ............................................................................3-2 Normal Mode of Attachment ............................................3-3 Operating Temperatures..................................................3-4 Shock Levels ...................................................................3-4 Cleaning..........................................................................3-4 Disposal ..........................................................................3-5

Construction.........................................................................3-5

Appendixes A Specifications ......................................................................A-1

B NRC Documents and License ..............................................B-1 Part 19 -- Notices, Instructions And Reports To Workers:

Inspection And Investigations..........................................B-6 Part 20—Standards for Protection Against Radiation...........B-10 Part 21—Reporting of Defects and Noncompliance ..............B-48 Part 30—Rules of General Applicability to Domestic

Licensing of Byproduct Material ....................................B-53 Part 31—General Domestic Licenses for Byproduct

Material.........................................................................B-79

xii Model 3077/3077A Aerosol Neutralizers

C Technical Paper ...................................................................C-1

Figures 1 Exterior Label ....................................................................... ix 2 Exterior Label ....................................................................... ix

3-1 Model 3077 Aerosol Neutralizers with Inlet and Outlet Tubes ..............................................................................3-3

Tables 2-1 Distribution of Charges on Aerosol Particles According

to Gunn Formulas...........................................................2-1

A-1 Model 3077 Aerosol Neutralizer Specifications....................A-1 A-2 Model 3077A Aerosol Neutralizer Specifications..................A-1 A-3 Model 3077/3077A Aerosol Neutralizer Radiation

Levels ..............................................................................A-2

C-1 Approximation Coefficient ai(N) ..........................................C-1

About This Manual

xiii

Purpose This is an instruction manual for the operation and handling of the Model 3077 and Model 3077A Aerosol Neutralizers.

Organization The following is a guide to the organization of the manual: ❑ Chapter 1: Product Overview This chapter serves as an introduction to the Model 3077 and

3077A Aerosol Neutralizers. ❑ Chapter 2: Principle of Operation This chapter contains the principle of operation for the

Model 3077 and 3077A Aerosol Neutralizers. ❑ Chapter 3: Neutralizer Measurements, Handling, and Con-

struction This chapter contains information you need when installing an

Aerosol Neutralizer in a sampling system, including information on dosage and disposal.

❑ Appendix A: Specifications This chapter gives the operating specifications for the

Model 3077 and 3077A Aerosol Neutralizers. ❑ Appendix B: NRC Documents and License This appendix contains portions of the Unites States Nuclear

Regulatory Commission (NRC) Rules and Regulation as well as the Materials License.

❑ Appendix C: Technical Paper This appendix contains a technical paper by A. Wiedensohler.

xiv Model 3077/3077A Aerosol Neutralizers

Related Product Literature ❑ Model 3080 Electrostatic Classifier Instruction Manual (part

number 1933792) TSI Incorporated

This manual contains operating instructions for the Model 3080 Electrostatic Classifier, an instrument used to generate, meas-ure, and sample aerosols and is a main component of the DMPS and SMPS systems.

❑ Model 3071A Electrostatic Classifier Instruction Manual

(part number 1933765) TSI Incorporated

This manual contains operating instructions for the Model 3071A Electrostatic Classifier, an instrument used to generate, measure, and sample aerosols and is a main compo-nent of the DMPS and SMPS systems.

Getting Help To obtain assistance with this product, or simply to submit sugges-tions, please contact Customer Service:

TSI Incorporated (Particle Instruments) 500 Cardigan Road Shoreview, MN 55126 USA Fax: (651) 490-3824 E-mail Address: [email protected] Telephone: 1-800-874-2811 (USA) or (651) 490-2811

Reusing and Recycling

As part of TSI Incorporated’s effort to have a minimal negative impact on the communities in which its products are manu-factured and used:

❑ This manual uses recyclable paper.

❑ This manual has been shipped, along with the instrument, in a reusable carton.

About This Manual xv

Submitting Comments TSI values your comments and suggestions on this manual. Please use the comment sheet, on the last page of this manual, to send us your opinion on the manual’s usability, to suggest specific im-provements, or to report any technical errors.

If the comment sheet has already been used, mail your comments on another sheet of paper to:

TSI Incorporated Particle Instruments 500 Cardigan Road Shoreview, MN 55126 Fax: (651) 490-3824 E-mail Address: [email protected]

Chapter 1 Product Overview

1-1

The Model 3077 Aerosol Neutralizer, containing 2 millicuries of Krypton-85 and the Model 3077A Aerosol Neutralizer, containing 10 millicuries of Krypton-85, are designed to neutralize electrostatic charges on aerosol particles as they pass through the device. The Neutralizer is usually plumbed into an aerosol sampling sys-tem, like TSI’s DMPS (Differential Mobility Particle Sizer) or SMPS (Scanning Mobility Particle Sizer) systems or in the Model 3080 Electrostatic Classifier. The Neutralizers are intended for an aerosol throughput of less than 5 liters per minute. See Appendix A, “Specifications,” for other operating specifications.

1-2 Model 3077/3077A Aerosol Neutralizers

Chapter 2 Principle of Operation

2-1

The Model 3077 Series Aerosol Neutralizers neutralize aerosol par-ticles by producing both positive and negative air ions that are at-tracted to oppositely charged particles. Given sufficient residence time in the Neutralizer, the charge level on the aerosol particles is reduced to the equilibrium level shown in Table 2-1. Note: The distribution of charges in Table 2-1 is slightly different

than the Boltzmann equilibrium charge level. The information in Table-2 was computed from information contained in “An Approximation of the Bipolar Charge Distribution for Particles in the Submicron Size Range” by A. Wiedensohler, Process and Aerosol Measurement Technology, University of Duisburg, Bismarckstr, 81, D-4100 Duisburg 1, F.R.G., published in the Journal of Aerosol Science, Vol. 19, No. 3, pp. 387–389, 1988, Printed in Great Britain

Table 2-1 Distribution of Charges on Aerosol Particles According to Gunn Formulas

Percent of Particle Carrying Np Elementary Charge Units Dp(µm) Np=–6 –5 –4 –3 –2 –1 0 +1 +2 +3 +4 +5 +6

0.01 5.14 90.75 4.11

0.02 0.02 10.96 80.57 8.64 0.01

0.04 0.54 19.50 64.79 14.86 0.31

0.06 0.02 1.92 24.32 54.13 18.51 1.09 0.01

0.08 0.11 3.73 26.81 46.75 20.46 2.10 0.05

0.10 0.37 5.63 27.31 42.28 20.91 3.30 0.17

0.20 0.05 0.53 3.40 12.38 25.49 29.66 19.51 7.26 1.53 0.18 0.01

0.40 0.27 1.14 3.60 8.54 15.24 20.46 20.65 15.66 8.93 3.83 1.24 0.03 0.05

0.60 1.21 3.00 6.19 10.53 14.82 17.25 16.60 13.20 8.69 4.73 2.13 0.79 0.24

0.80 2.42 4.64 7.71 11.12 13.90 15.06 14.15 11.53 8.15 4.99 2.65 1.22 0.49

1.00 3.56 5.84 8.53 11.13 12.96 13.45 12.46 10.30 7.59 5.00 2.93 1.54 0.92

Chapter 3 Neutralizer Measurement, Handling, and Construction

3-1

This chapter contains information you need to use the Model 3077 Series Aerosol Neutralizers in an aerosol sampling system:

❑ Radiation measurements for the Neutralizer

❑ Handling information including dosage, the normal means of at-taching the Neutralizer in an aerosol sampling system, operat-ing temperature, cleaning, and disposal

❑ Neutralizer construction.

Radiation Measurements This section includes information for a 15 millicurie neutralizer based on measurements made of the radiation levels near the Aero-sol Neutralizer using a Model 2 Geiger Counter (S/N 95727), Lud-lum Measurements, Inc. Measurements were made on a TSI Model 3077 Aerosol Neutralizer (S/N 1459T) and scaled up to reflect the higher activity level. 15 millicuries is the maximum activity a Model 3077 series neutralizer may contain.

Results are as follows:

❑ Surface radiation levels on the side closest to the Kr-85 source and at the midline of the source are calculated to be 41.1 milliroentgen per hour.

❑ Calculations made at 6 inches and 12 inches from the surface of the Neutralizer at the center of the Kr-85 source within the Neutralizer indicate levels equal to 1.2 milliroentgens per hour and 0.82 milliroentgens per hour, respectively.

Handling Information This section gives information on the proper handling of the Model 3077 Series Aerosol Neutralizers, including dosage, normal way of attaching the Neutralizer in a sampling system, operating specifications, cleaning, and disposal. Also refer to the information in the Safety section at the front of this manual.


Dosage TSI Incorporated Aerosol Neutralizers are designed to be installed into aerosol distribution lines. The devices are self-contained and once installed no further handling or maintenance except for an oc-casional cleaning is required. Therefore, per 10 CFR Part 32.51 (a)(2)(i) no special training is required. The maximum probable dosage would occur during maintenance cleaning of the device and should not exceed one hour in duration. Assuming a one month cleaning frequency—once per 12 months is probably more reasonable—the maximum expected dose to the hands would be: 0.0411 rems/hr x 1 hour per month x 12 months per year = 0.493 rems per year. This limit is well under the limit of 10% x 50 rems = 5 rems to the skin or any extremity that is allowed per 10 CFR Part 32.51 (a)(2)(ii). It is unlikely that any operator involved with handling, storing, or using the Neutralizer will be within 12 inches of a Neutralizer for more than 1 hour per day. A calculation of the activity 12 inches from the outer surface for one hour per day for a year gives: 0.00082 rems/hr x 1 hour/day x 5 days/week x 52 weeks/year = 0.213 rems per year. Again this limit is well under 10% of the annual limits that are al-lowed per 10 CFR Part 32.51 (a)(2)(ii). Even if this is a whole body dosage, it is well below the limit of 0.5 rems per year allowed by 10 CFR Part 32.51(a)(2)(ii). The worst possible accident, considering radiation exposure, would result in the sudden release of the Kr-85 into the atmosphere. The smallest room in which a Neutralizer is normally stored, handled, or used is about 3 meters by 3 meters by 3 meters in volume = 27,000,000 cm3. If 15 millicuries of Kr-85 are released into this room, the concentration will be 15,000 ÷ 27,000,000 = 5.55 × 10–4 microcuries per cm3. A typical occupied room of this size will have a ventilation rate in excess of 3 air changes per hour. After 4 hours the average concentration would be reduced by a factor of 12 to give a concentration of 4.63 × 10–5 microcurie per milliliter. Thus,

Neutralizer Measurement, Handling, and Construction 3-3

after 4 hours the concentration is less than the DAC concentration of 1 × 10–4 microcuries per milliliter of Kr-85 for one year allowed in 10 CFR Part 20 Appendix B. Therefore, it is unlikely that any indi-vidual will exceed the limits that are allowed per 10 CFR Part 32.51(a)(2)(iii). Using the above examples, it is highly unlikely that, under accident conditions, any operator will receive an external radiation dose in excess of the specified limits.

Normal Mode of Attachment The normal mode of attachment of the Neutralizer to other aerosol apparatus is by use of a standard Swagelok-type fitting to each tube, inlet and outlet, or by a connecting piece of vinyl or rubber tubing (see Figure 3-1). If you are installing the Neutralizer in a Classifier, use the instructions in the Electrostatic Classifier man-ual. The mechanical stress applied to the Neutralizer during attachment and use is minimal compared to the stress needed to break or de-stroy the Neutralizer or its parts and no other condition of extreme mechanical stress is expected.

6.1 in..96 in. 1.56 in. 1.5 in.Diameter

Outlet Tube

Outer Tube

Bracket, Kr-85Source Holder

Inlet Tube

Bracket, Kr-85Source Holder

Figure 3-1 Model 3077 Aerosol Neutralizers with Inlet and Outlet Tubes


Operating Temperatures Even though the maximum specified operating temperature of the Aerosol Neutralizer is 50°C, the epoxy and all other structural com-ponents will withstand at least 90°C without significant damage. Temperatures well below –20°C will not damage the Aerosol Neu-tralizer even though –20°C is the minimum specified operating temperature.

Shock Levels The maximum expected abuse will be shock during shipment and shock from falling off a work bench to the floor. Dropping the Neu-tralizer from a work bench or storage shelf to a floor 2.5 meters be-low will not damage the functional integrity of the device. The construction methods and materials are sufficient to withstand shock levels in excess of any expected shock levels. However, do not abuse the Neutralizer by dropping it, cutting it, or deforming it in any way.

Cleaning Over time and depending on the material used in the sampling sys-tem, the Neutralizer may become coated internally with aerosol. You can safely clean the Neutralizer by rinsing it with cool, clean water.

W A R N I N G The use of controls, adjustments, or procedures other than those specified in this manual may result in exposure to hazardous radiation.

❑ Do not use water above 50°C. Temperatures above 50°C can

degrade materials that are a part of the Neutralizer (303, 304, or 316 stainless steel, copper, silver solder or epoxy), causing the Neutralizer to leak radioactive contamination.

❑ Do not fill the Neutralizer with water and then shake it. This could cause sufficient mechanical shock to damage the Krypton source causing it to leak. Instead, allow water to flow through the Neutralizer.

Neutralizer Measurement, Handling, and Construction 3-5

1. Remove the Neutralizer from the cabinet. Pour clean alcohol or soapy water into one end.

2. Hold both ends of the Neutralizer and gently tip back and forth.

3. Drain the liquid from the end of the Neutralizer that has the longest exterior tube. Repeat several times, if necessary.

4. Thoroughly rinse with clean water, air dry and reinstall into the Classifier.

Disposal The Neutralizer contains 2 or 10 millicuries of Kr-85 with a half-life of over 10 years. At the end of 10 years, TSI recommends you re-turn the Model 3077 Aerosol Neutralizer and replace it with a new one. Any disposal must be performed in accordance with NRC and local regulations. If you have no other acceptable method of disposal, return the Neu-tralizer to TSI using the original DOT-approved packing material. If you no longer have the original packing material, package and ship the Neutralizer using acceptable NRC and DOT procedures.

Construction Under ordinary conditions of TSI and customer handling, storage, and use of the Aerosol Neutralizer, the Type 316 stainless-steel tube containing the Kr-85 cannot be released or removed from the Neutralizer housing. The entire Neutralizer housing is constructed of stainless steel. All joints are epoxied for both mechanical assembly and for an air-tight seal. The stainless-steel-sealed Kr-85 source is epoxied to 2 stainless-steel brackets, which are in turn fastened to the inner wall of the outer tube with two stainless-steel, tamper-proof screws. The tamper-proof screws are epoxied to the outside of the outer tube to prevent their removal and to form an air-tight seal.


Even if the source should somehow, by willful destruction or un-foreseen event, become separated from the two screws, the source epoxied to the brackets cannot come out of the outer tube assembly except by mechanical destruction of the entire assembly. The heavy stainless-steel end plates of the entire assembly are ep-oxied in place for mechanical rigidity as well as for an air-tight seal. The stainless-steel aerosol inlet and outlet tubes are epoxied in place to prevent disassembly and to provide an air-tight seal. The location and dimensions of the inlet and outlet tubes with respect to the Kr-85 source prevent any direct line-of-sight between the source and the exterior of the aerosol neutralizer. The thickness and strength of the entire housing will resist all but the most violent explosions and hottest fires. A fire or explosion vio-lent enough to destroy the housing or source will disperse the Kr-85 gas so quickly as to pose a much greater danger to nearby per-sons by fire or explosion than by radiation. TSI Incorporated certifies that the Aerosol Neutralizer has been constructed and leak tested in accordance with NRC General Li-cense No. 22-12602-03G issued to TSI.

Appendix A Specifications

A-1

The specifications in Table A-1, subject to change, apply to the Model 3077 Aerosol Neutralizer. Table A-1 Model 3077 Aerosol Neutralizer Specifications

Source ................................................. Kr-85

Radioactivity ...................................... 2 millicurie

Half-life ............................................... 10.7 years

Flowrate (maximum) ........................... 5 L/min

Temperature (maximum) .................... 50°C

Pressure (maximum) ........................... 5 psig

Outer Housing Materials ..................... Stainless steel

Dimensions: Inlet diameter ..................................... 0.64 cm (0.25 in.) Outlet diameter .................................. 0.64 cm (0.25 in.) Diameter ............................................ 3.89 cm (1.53 in.) Length ................................................ 21.44 cm (8.44 in.)

Weight ................................................. 0.4 kg (0.9 lb.)

The specifications in Table A-2, subject to change, apply to the Model 3077A Aerosol Neutralizer. Table A-2 Model 3077A Aerosol Neutralizer Specifications

Source ................................................. Kr-85

Radioactivity ...................................... 10 millicurie

Half-life ............................................... 10.7 years

Flowrate (maximum) ........................... 5 L/min

Temperature (maximum) .................... 50°C

Pressure (maximum) ........................... 5 psig

Outer Housing Materials ..................... Stainless steel

Dimensions: Inlet diameter ..................................... 0.64 cm (0.25 in.) Outlet diameter .................................. 0.64 cm (0.25 in.) Diameter ............................................ 3.89 cm (1.53 in.) Length ................................................ 21.44 cm (8.44 in.)

Weight ................................................. 0.4 kg (0.9 lb.)

A-2 Model 3077/3077A Aerosol Neutralizers

The following table gives the time in hours to receive a dose of 100 millirems (1,000 µSv) from the specified neutralizer at the dis-tances shown for different activity levels. For comparison purposes it is estimated that the average person in the United States receives approximately 600 millirems (6,000 µSv) per year from natural background (500 millirems) and man made (100 millirems) sources of radiation.

Table A-3 Model 3077/3077A Aerosol Neutralizer Radiation Levels

Distance hours to hours to hours to inches 100 mrem 100 mrem 100 mrem (cm) 2 mCi (74 MBq) 10 mCi (370 MBq) 15 mCi (555 MBq)

6 (15.2) 625 125 83 12 (30.5) 915 183 122 24 (61.0) 1798 360 240

40 (101.6) 3572 714 476 60 (152.4) 6904 1381 921 80 (203.2) 11715 2343 1562 100 (254.0) 18284 3657 2438

Appendix B NRC Documents and License

B-1

The following United States Nuclear Regulatory Commission (NRC) Rules and Regulations are presented in this appendix:

❑ Materials License No. 22-12602-03G

❑ Part 19—Notices, Instructions and Reports to Workers: Inspec-tion and Investigations

❑ Part 20—Standards for Protection Against Radiation

❑ Part 21—Reporting of Defects and Noncompliance

❑ Part 30—Rules of General Applicability to Domestic Licensing of Byproduct Material

❑ Part 31—General Domestic Licenses for Byproduct Material

B-2 Model 3077/3077A Aerosol Neutralizers

Model 3077/3077A Aerosol Neutralizers B-3

NRC Documents and License B-5


PART 19 -- NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION AND INVESTIGATIONS Sec. 19.1 Purpose. 19.2 Scope. 19.3 Definitions. 19.4 Interpretations. 19.5 Communications. 19.8 Information collection re-quirements: OMB approval. 19.11 Posting of notices to workers. 19.12 Instruction to workers. 19.13 Notifications and reports to individuals. 19.14 Presence of representatives of licensees and workers during in-spections. 19.15 Consultation with workers during inspections. 19.16 Requests by workers for in-spections. 19.17 Inspections not warranted; informal review. 19.18 Sequestration of witnesses and exclusion of counsel in inter-views conducted under subpoena. 19.20 Employee protection. 19.30 Violations. 19.31 Application for exemptions. 19.32 Discrimination prohibited. 19.40 Criminal penalties. Authority: Secs. 53, 63, 81, 103, 104, 161, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 955, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2236, 2282, 2297f); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); Pub. L. 95 - 601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851). Source: 38 FR 22217, Aug. 17, 1973, unless otherwise noted. §19.1 Purpose. The regulations in this part es-tablish requirements for notices, instructions, and reports by licen-sees to individuals participating in licensed activities and options available to these individuals in connection with Commission in-spections of licensees to ascertain compliance with the provisions of the Atomic Energy Act of 1954, as amended, title II of the Energy Re-organization Act of 1974, and regu-lations, orders, and licenses

thereunder regarding radiological working conditions. The regulations in this part also establish the rights and responsibilities of the Commis-sion and individuals during inter-views compelled by subpoena as part of agency inspections or inves-tigations pursuant to section 161c of the Atomic Energy Act of 1954, as amended, on any matter within the Commission's jurisdiction. [55 FR 247, Jan. 4, 1990] §19.2 Scope. The regulations in this part ap-ply to all persons who receive, pos-sess, use, or transfer material licensed by the Nuclear Regulatory Commission pursuant to the regu-lations in parts 30 through 36, 39, 40, 60, 61, 63, 70, or part 72 of this chapter, including persons li-censed to operate a production or utilization facility under part 50 of this chapter, persons licensed to possess power reactor spent fuel in an independent spent fuel storage installation (ISFSI) pursuant to part 72 of this chapter, and in accor-dance with 10 CFR 76.60 to per-sons required to obtain a certificate of compliance or an approved com-pliance plan under part 76 of this chapter. The regulations regarding interviews of individuals under subpoena apply to all investigations and inspections within the jurisdic-tion of the Nuclear Regulatory Commission other than those in-volving NRC employees or NRC con-tractors. The regulations in this part do not apply to subpoenas is-sued pursuant to 10 CFR 2.720. [59 FR 48959, Sept. 23, 1994, as amended at 61 FR 9902, Mar. 12, 1996] §19.3 Definitions. As used in this part: Act means the Atomic Energy Act of 1954, (68 Stat. 919) includ-ing any amendments thereto. Commission means the United States Nuclear Regulatory Commis-sion. Exclusion means the removal of counsel representing multiple in-terests from an interview whenever the NRC official conducting the in-terview has concrete evidence that the presence of the counsel would obstruct and impede the particular investigation or inspection.

License means a license issued under the regulations in parts 30 through 36, 39, 40, 60, 61, 63, 70, or 72 of this chapter, including li-censes to operate a production or utilization facility pursuant to part 50 of this chapter. Licensee means the holder of such a license. Restricted area means an area, access to which is limited by the licensee for the purpose of protect-ing individuals against undue risks from exposure to radiation and ra-dioactive materials. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area. Sequestration means the separa-tion or isolation of witnesses and their attorneys from other wit-nesses and their attorneys during an interview conducted as part of an investigation, inspection, or other inquiry. Worker means an individual en-gaged in activities licensed by the Commission and controlled by a licensee, but does not include the licensee. [38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 53 FR 31680, Aug. 19, 1988; 55 FR 247, Jan. 4, 1990; 56 FR 23470, May 21, 1991; 56 FR 65948, Dec. 19, 1991; 57 FR 61785, Dec. 29, 1992; 58 FR 7736, Feb. 9, 1993] §19.4 Interpretations. Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any offi-cer or employee of the Commission other than a written interpretation by the General Counsel will be rec-ognized to be binding upon the Commission. §19.5 Communications. Except where otherwise specified in this part, all communications and reports concerning the regula-tions in this part should be ad-dressed to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commis-sion Regional Office listed in ap-pendix D of part 20 of this chapter. Communications, reports, and ap-plications may be delivered in per-son at the Commission's offices at


2120 L Street, NW., Washington, DC, or at 11555 Rockville Pike, Rockville, Maryland. [53 FR 6138, Mar. 1, 1988, as amended at 53 FR 43420, Oct. 27, 1988]

§19.8 Information collection re-quirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the in-formation collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Pa-perwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a col-lection of information unless it dis-plays a currently valid OMB control number. OMB has approved the information collection requirements contained in the part under control number 3150-0044. (b) The approved information collection requirements contained in this part appear in §§19.13 and 19.16. [62 FR 52185, Oct. 6, 1997] §19.11 Posting of notices to workers. (a) Each licensee shall post cur-rent copies of the following docu-ments: (1) The regulations in this part and in part 20 of this chapter; (2) The license, license condi-tions, or documents incorporated into a license by reference, and amendments thereto; (3) The operating procedures applicable to licensed activities; (4) Any notice of violation involv-ing radiological working conditions, proposed imposition of civil pen-alty, or order issued pursuant to subpart B of part 2 of this chapter, and any response from the licensee. (b) If posting of a document specified in paragraph (a) (1), (2) or (3) of this section is not practicable, the licensee may post a notice which describes the document and states where it may be examined. (c)(1) Each licensee and each applicant for a specific license shall prominently post NRC Form 3, "No-tice to Employees," dated August 1997. Later versions of NRC Form 3 that supersede the August 1997 version shall replace the previously posted version within 30 days of

receiving the revised NRC Form 3 from the Commission. (c)(2) Additional copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the appropriate U.S. Nuclear Regula-tory Commission Regional Office listed in Appendix D to Part 20 of this chapter or by calling the NRC Information and Records Manage-ment Branch at 301-415-7232. (d) Documents, notices, or forms posted pursuant to this section shall appear in a sufficient number of places to permit individuals en-gaged in licensed activities to ob-serve them on the way to or from any particular licensed activity lo-cation to which the document ap-plies, shall be conspicuous, and shall be replaced if defaced or al-tered. (e) Commission documents posted pursuant to paragraph (a)(4) of this section shall be posted within 2 working days after receipt of the documents from the Com-mission; the licensee's response, if any, shall be posted within 2 work-ing days after dispatch by the li-censee. Such documents shall remain posted for a minimum of 5 working days or until action cor-recting the violation has been com-pleted, whichever is later. [38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 47 FR 30454, July 14, 1982; 58 FR 52408, Oct. 8, 1993; 60 FR 24551, May 9, 1995; 61 FR 6764, Feb. 22, 1996; 62 FR 48166, Sept. 15, 1997] §19.12 Instruction to workers. (a) All individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) shall be -- (1) Kept informed of the storage, transfer, or use of radiation and/or radioactive material; (2) Instructed in the health pro-tection problems associated with exposure to radiation and/or radio-active material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed; (3) Instructed in, and required to observe, to the extent within the workers control, the applicable pro-visions of Commission regulations and licenses for the protection of

personnel from exposure to radia-tion and/or radioactive material; (4) Instructed of their responsi-bility to report promptly to the li-censee any condition which may lead to or cause a violation of Commission regulations and li-censes or unnecessary exposure to radiation and/or radioactive mate-rial; (5) Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve expo-sure to radiation and/or radioactive material; and (6) Advised as to the radiation exposure reports which workers may request pursuant to §19.13. (b) In determining those indi-viduals subject to the requirements of paragraph (a) of this section, li-censees must take into considera-tion assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to oc-cur during the life of a licensed fa-cility. The extent of these instructions must be commensu-rate with potential radiological health protection problems present in the work place. [60 FR 36043, July 13, 1995] §19.13 Notifications and reports to individuals. (a) Radiation exposure data for an individual, and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual, shall be reported to the individual as specified in this section. The information reported shall include data and results ob-tained pursuant to Commission regulations, orders or license condi-tions, as shown in records main-tained by the licensee pursuant to Commission regulations. Each noti-fication and report shall: be in writ-ing; include appropriate identifying data such as the name of the licen-see, the name of the individual, the individual's social security number; include the individual's exposure information; and contain the follow-ing statement: This report is furnished to you under the provisions of the Nuclear Regulatory Commission regulation 10 CFR part 19. You should pre-


serve this report for further refer-ence. (b) Each licensee shall advise each worker annually of the worker's dose as shown in records maintained by the licensee pursu-ant to the provisions of §20.2106 of 10 CFR part 20. (c)(1) At the request of a worker formerly engaged in licensed activi-ties controlled by the licensee, each licensee shall furnish to the worker a report of the worker's exposure to radiation and/or to radioactive ma-terial: (i) As shown in records main-tained by the licensee pursuant to §20.2106 for each year the worker was required to be monitored under the provisions of §20.1502; and (ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to January 1, 1994. (2) This report must be furnished within 30 days from the time the request is made or within 30 days after the exposure of the individual has been determined by the licen-see, whichever is later. This report must cover the period of time that the worker's activities involved ex-posure to radiation from radioactive material licensed by the Commis-sion and must include the dates and locations of licensed activities in which the worker participated during this period. (d) When a licensee is required pursuant to §§20.2202, 20.2203, 20.2204, or 20.2206 of this chapter to report to the Commission any exposure of an individual to radia-tion or radioactive material the li-censee shall also provide the individual a report on his or her exposure data included therein. This report must be transmitted at a time not later than the transmit-tal to the Commission. (e) At the request of a worker who is terminating employment with the licensee that involved ex-posure to radiation or radioactive materials, during the current cal-endar quarter or the current year, each licensee shall provide at ter-mination to each worker, or to the worker's designee, a written report regarding the radiation dose re-ceived by that worker from opera-tions of the licensee during the current year or fraction thereof. If the most recent individual monitor-

ing results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an es-timate. [38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 44 FR 32352, June 6, 1979; 58 FR 67658, Dec. 22, 1993; 59 FR 41642, Aug. 15, 1994] §19.14 Presence of representa-tives of licensees and workers during inspections. (a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect mate-rials, activities, facilities, premises, and records pursuant to the regula-tions in this chapter. (b) During an inspection, Com-mission inspectors may consult privately with workers as specified in §19.15. The licensee or licensee's representative may accompany Commission inspectors during other phrases of an inspection. (c) If, at the time of inspection, an individual has been authorized by the workers to represent them during Commission inspections, the licensee shall notify the inspec-tors of such authorization and shall give the workers' representative an opportunity to accompany the in-spectors during the inspection of physical working conditions. (d) Each workers' representative shall be routinely engaged in li-censed activities under control of the licensee and shall have received instructions as specified in §19.12. (e) Different representatives of licensees and workers may accom-pany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspec-tors. (f) With the approval of the licen-see and the workers' representative an individual who is not routinely engaged in licensed activities under control of the license, for example, a consultant to the licensee or to the workers' representative, shall be afforded the opportunity to ac-company Commission inspectors during the inspection of physical working conditions. (g) Notwithstanding the other provisions of this section, Commis-

sion inspectors are authorized to refuse to permit accompaniment by any individual who deliberately in-terferes with a fair and orderly in-spection. With regard to areas containing information classified by an agency of the U.S. Government in the interest of national security, an individual who accompanies an inspector may have access to such information only if authorized to do so. With regard to any area con-taining proprietary information, the workers' representative for that area shall be an individual previ-ously authorized by the licensee to enter that area. §19.15 Consultation with work-ers during inspections. (a) Commission inspectors may consult privately with workers con-cerning matters of occupational radiation protection and other mat-ters related to applicable provisions of Commission regulations and li-censes to the extent the inspectors deem necessary for the conduct of an effective and thorough inspec-tion. (b) During the course of an in-spection any worker may bring pri-vately to the attention of the inspectors, either orally or in writ-ing, any past or present condition which he has reason to believe may have contributed to or caused any violation of the act, the regulations in this chapter, or license condi-tion, or any unnecessary exposure of an individual to radiation from licensed radioactive material under the licensee's control. Any such notice in writing shall comply with the requirements of §19.16(a). (c) The provisions of paragraph (b) of this section shall not be in-terpreted as authorization to disre-gard instructions pursuant to §19.12. §19.16 Requests by workers for inspections. (a) Any worker or representative of workers who believes that a vio-lation of the Act, the regulations in this chapter, or license conditions exists or has occurred in license activities with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Administra-tor of the appropriate Commission


Regional Office, or to Commission inspectors. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of workers. A copy shall be provided the licensee by the Regional Office Administrator, or the inspector no later than at the time of inspection except that, upon the request of the worker giv-ing such notice, his name and the name of individuals referred to therein shall not appear in such copy or on any record published, released or made available by the Commission, except for good cause shown. (b) If, upon receipt of such no-tice, the Regional Office Adminis-trator determines that the complaint meets the requirements set forth in paragraph (a) of this section, and that there are reason-able grounds to believe that the alleged violation exists or has oc-curred, he shall cause an inspec-tion to be made as soon as practicable, to determine if such alleged violation exists or has oc-curred. Inspections pursuant to this section need not be limited to matters referred to in the com-plaint. [38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 47 FR 30454, July 14, 1982; 52 FR 31610, Aug. 21, 1987] §19.17 Inspections not war-ranted; informal review. (a) If the Administrator of the appropriate Regional Office deter-mines, with respect to a complaint under §19.16, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, he shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the Executive Director for Opera-tion, U.S. Nuclear Regulatory Commission, Washington, DC 20555, who will provide the licen-see with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The li-censee may submit an opposing written statement of position with the Executive Director for Opera-

tions who will provide the com-plainant with a copy of such statement by certified mail. Upon the request of the complainant, the Executive Director for Operations or his designee may hold an infor-mal conference in which the com-plainant and the licensee may orally present their views. An in-formal conference may also be held at the request of the licensee, but disclosure of the identity of the complainant will be made only fol-lowing receipt of written authoriza-tion from the complainant. After considering all written and oral views presented, the Executive Di-rector for Operations shall affirm, modifying, or reverse the determi-nation of the Administrator of the appropriate Regional Office and furnish the complainant and the licensee a written notification of his decision and the reason therefor. (b) If the Administrator of the appropriate Regional Office deter-mines that an inspection is not warranted because the require-ments of §19.16(a) have not been met, he shall notify the complain-ant in writing of such determina-tion. Such determination shall be without prejudice to the filing of a new complaint meeting the re-quirements of §19.16(a). [38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 52 FR 31610, Aug. 21, 1987] §19.18 Sequestration of wit-nesses and exclusion of counsel in interviews conducted under subpoena. (a) All witnesses compelled by subpoena to submit to agency in-terviews shall be sequestered unless the official conducting the interviews permits otherwise. (b) Any witness compelled by subpoena to appear at an interview during an agency inquiry may be accompanied, represented, and advised by counsel of his or her choice. However, when the agency official conducting the inquiry de-termines, after consultation with the Office of the General Counsel, that the agency has concrete evi-dence that the presence of an at-torney representing multiple interests would obstruct and im-pede the investigation or inspec-tion, the agency official may

prohibit that counsel from being present during the interview. (c) The interviewing official is to provide a witness whose counsel has been excluded under para-graph (b) of this section and the witness's counsel a written state-ment of the reasons supporting the decision to exclude. This statement, which must be provided no later than five working days after exclu-sion, must explain the basis for the counsel's exclusion. This statement must also advise the witness of the witness' right to appeal the exclu-sion decision and obtain an auto-matic stay of the effectiveness of the subpoena by filing a motion to quash the subpoena with the Commission within five days of re-ceipt of this written statement. (d) Within five days after receipt of the written notification required in paragraph (c) of this section, a witness whose counsel has been excluded may appeal the exclusion decision by filing a motion to quash the subpoena with the Commis-sion. The filing of the motion to quash will stay the effectiveness of the subpoena pending the Commis-sion's decision on the motion. (e) If a witness' counsel is ex-cluded under paragraph (b) of this section, the interview may, at the witness' request, either proceed without counsel or be delayed for a reasonable period of time to permit the retention of new counsel. The interview may also be rescheduled to a subsequent date established by the NRC, although the interview shall not be rescheduled by the NRC to a date that precedes the expiration of the time provided un-der §19.18(d) for appeal of the ex-clusion of counsel, unless the witness consents to an earlier date. [55 FR 247, Jan. 4, 1990, as amended at 56 FR 65948, Dec. 19, 1991; 57 FR 61785, Dec. 29, 1992] §19.20 Employee protection. Employment discrimination by a licensee (or a holder of a certificate of compliance issued pursuant to part 76) or a contractor or subcon-tractor of a licensee (or a holder of a certificate of compliance issued pursuant to part 76) against an employee for engaging in protected activities under this part or parts 30, 40, 50, 60, 61, 63, 70, 72, 76,


or 150 of this chapter is prohibited. Title: Part: [61 FR 6764, Feb. 22, 1996] §19.30 Violations. (a) The Commission may obtain an injunction or other court order to prevent a violation of the provi-sions of -- (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reor-ganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of -- (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limi-tation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under sec-tion 186 of the Atomic Energy Act of 1954, as amended. [57 FR 55071, Nov. 24, 1992] §19.31 Application for exemp-tions. The Commission may upon ap-plication by any licensee or upon its own initiative, grant such ex-emptions from the requirements of the regulations in this part as it determines are authorized by law and will not result in undue hazard to life or property. §19.32 Discrimination prohib-ited. No person shall on the ground of sex be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity licensed by the Nuclear Regulatory Commis-sion. This provision will be enforced through agency provisions and rules similar to those already es-tablished, with respect to racial and

other discrimination, under Title VII of the Civil Rights Act of 1964. This remedy is not exclusive, how-ever, and will not prejudice or cut off any other legal remedies avail-able to a discriminatee. §19.40 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted viola-tion of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 19 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 19 that are not issued under sections 161b, 161i, or 161o for the pur-poses of section 223 are as follows: §§19.1, 19.2, 19.3, 19.4, 19.5, 19.8, 19.16, 19.17, 19.18, 19.30, 19.31, and 19.40. [57 FR 55071, Nov. 24, 1992] PART 20 -- STANDARDS FOR PROTECTION AGAINST RADIATION Subpart A -- General Provisions Source: 56 FR 23391, May 21,

1991, unless otherwise noted. 20.1001 Purpose. 20.1002 Scope. 20.1003 Definitions. 20.1004 Units of radiation dose. 20.1005 Units of radioactivity. 20.1006 Interpretations. 20.1007 Communications. 20.1008 Implementation. 20.1009 Reporting, recording, and

application requirements: OMB approval.

Subpart B -- Radiation Protection Programs Source: 56 FR 23396, May 21,

1991, unless otherwise noted. 20.1101 Radiation protection pro-

grams. Subpart C -- Occupational Dose Limits Source: 56 FR 23396, May 21,

1991, unless otherwise noted.

20.1201 Occupational dose limits for adults.

20.1202 Compliance with require-ments for summation of external and internal doses.

20.1203 Determination of external dose from airborne radioactive material.

20.1204 Determination of internal exposure.

20.1205 [Reserved] 20.1206 Planned special exposures. 20.1207 Occupational dose limits

for minors. 20.1208 Dose to an embryo/fetus. Subpart D -- Radiation Dose Lim-its for Individual Members of the Public Source: 56 FR 23398, May 21,

1991, unless otherwise noted. 20.1301 Dose limits for individual

members of the public. 20.1302 Compliance with dose lim-

its for individual members of the public.

Subpart E -- Radiological Criteria for License Termination 20.1401 General provisions and

scope. 20.1402 Radiological criteria for

unrestricted use. 20.1403 Criteria for license termi-

nation under restricted condi-tions.

20.1404 Alternate criteria for li-cense termination.

20.1405 Public notification and public participation.

20.1406 Minimization of contami-nation.

Subpart F -- Surveys and Moni-toring Source: 56 FR 23398, May 21,

1991, unless otherwise noted. 20.1501 General. 20.1502 Conditions requiring indi-

vidual monitoring of external and internal occupational dose.

Subpart G -- Control of Exposure From External Sources in Re-stricted Areas Source: 56 FR 23398, May 21,

1991, unless otherwise noted. 20.1601 Control of access to high

radiation areas. 20.1602 Control of access to very

high radiation areas.


Subpart H -- Respiratory Protec-tion and Controls to Restrict In-ternal Exposure in Restricted Areas Source: 56 FR 23400, May 21,

1991, unless otherwise noted. 20.1701 Use of process or other

engineering controls. 20.1702 Use of other controls. 20.1703 Use of individual respira-

tory protection equipment. 20.1704 Further restrictions on the

use of respiratory protection equipment.

Subpart I -- Storage and Control of Licensed Material Source: 56 FR 23401, May 21,

1991, unless otherwise noted. 20.1801 Security of stored mate-

rial. 20.1802 Control of material not in

storage. Subpart J -- Precautionary Pro-cedures Source: 56 FR 23401, May 21,

1991, unless otherwise noted. 20.1901 Caution signs. 20.1902 Posting requirements. 20.1903 Exceptions to posting re-

quirements. 20.1904 Labeling containers. 20.1905 Exemptions to labeling

requirements. 20.1906 Procedures for receiving

and opening packages. Subpart K -- Waste Disposal Source: 56 FR 23403, May 21,

1991, unless otherwise noted. 20.2001 General requirements. 20.2002 Method for obtaining ap-

proval of proposed disposal pro-cedures.

20.2003 Disposal by release into sanitary sewerage.

20.2004 Treatment or disposal by incineration.

20.2005 Disposal of specific wastes.

20.2006 Transfer for disposal and manifests.

20.2007 Compliance with environ-mental and health protection regulations.

Subpart L -- Records Source: 56 FR 23404, May 21,

1991, unless otherwise noted.

20.2101 General provisions. 20.2102 Records of radiation pro-

tection programs. 20.2103 Records of surveys. 20.2104 Determination of prior oc-

cupational dose. 20.2105 Records of planned special

exposures. 20.2106 Records of individual

monitoring results. 20.2107 Records of dose to individ-

ual members of the public. 20.2108 Records of waste disposal. 20.2109 [Reserved] 20.2110 Form of records. Subpart M -- Reports Source: 56 FR 23406, May 21,

1991, unless otherwise noted. 20.2201 Reports of theft or loss of

licensed material. 20.2202 Notification of incidents. 20.2203 Reports of exposures, ra-

diation levels, and concentra-tions of radioactive material exceeding the constraints or lim-its.

20.2204 Reports of planned special exposures.

20.2205 Reports to individuals of exceeding dose limits.

20.2206 Reports of individual monitoring.

Subpart N -- Exemptions and Ad-ditional Requirements Source: 56 FR 23408, May 21,

1991, unless otherwise noted. 20.2301 Applications for exemp-

tions. 20.2302 Additional requirements. Subpart O -- Enforcement 20.2401 Violations. 20.2402 Criminal penalties. Appendix A to Part 20 -- Protec-tion Factors for Respirators Appendix B to Part 20 -- Annual Limits on Intake (ALIs) and De-rived Air Concentrations (DACs) of Radionuclides for Occupa-tional Exposure; Effluent Con-centrations; Concentrations for Release to Sewerage Appendix C to Part 20 -- Quanti-ties of Licensed Material Requir-ing Labeling

Appendix D to Part 20 -- United States Nuclear Regulatory Com-mission Regional Offices Appendix E to Part 20 -- [Re-served] Appendix F to Part 20 -- [Re-served] Appendix G to Part 20 -- Re-quirements for Transfers of Low-Level Radioactive Waste In-tended for Disposal at Licensed Land Disposal Facilities and Manifests Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846). Subpart A -- General Provisions Source: 56 FR 23391, May 21,

1991, unless otherwise noted. §20.1001 Purpose. (a) The regulations in this part establish standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the Nuclear Regulatory Commission. These regulations are issued under the Atomic Energy Act of 1954, as amended, and the Energy Reor-ganization Act of 1974, as amended. (b) It is the purpose of the regu-lations in this part to control the receipt, possession, use, transfer, and disposal of licensed material by any licensee in such a manner that the total dose to an individual (in-cluding doses resulting from li-censed and unlicensed radioactive material and from radiation sources other than background radiation) does not exceed the standards for protection against radiation prescribed in the regula-tions in this part. However, nothing in this part shall be construed as limiting actions that may be neces-sary to protect health and safety.


§20.1002 Scope. The regulations in this part apply to persons licensed by the Commis-sion to receive, possess, use, trans-fer, or dispose of byproduct, source, or special nuclear material, or to operate a production or utilization facility under parts 30 through 36, 39, 40, 50, 60, 61, 63, 70, or 72 of this chapter, and in accordance with 10 CFR 76.60 to persons re-quired to obtain a certificate of compliance or an approved compli-ance plan under part 76 of this chapter. The limits in this part do not apply to doses due to back-ground radiation, to exposure of patients to radiation for the pur-pose of medical diagnosis or ther-apy, to exposure from individuals administered radioactive material and released in accordance with § 35.75, or to exposure from volun-tary participation in medical re-search programs. [63 FR 50128, Sept. 21, 1988] §20.1003 Definitions. As used in this part: Absorbed dose means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the rad and the gray (Gy). Act means the Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.), as amended. Activity is the rate of disintegra-tion (transformation) or decay of radioactive material. The units of activity are the curie (Ci) and the becquerel (Bq). Adult means an individual 18 or more years of age. Airborne radioactive material means radioactive material dis-persed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases. Airborne radioactivity area means a room, enclosure, or area in which airborne radioactive mate-rials, composed wholly or partly of licensed material, exist in concen-trations -- (1) In excess of the derived air concentrations (DACs) specified in appendix B, to §§20.1001 - 20.2401, or (2) To such a degree that an in-dividual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an

intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours. Air-purifying respirator means a respirator with an air-purifying fil-ter, cartridge, or canister that re-moves specific air contaminants by passing ambient air through the air-purifying element. ALARA (acronym for "as low as is reasonably achievable") means making every reasonable effort to maintain exposures to radiation as far below the dose limits in this part as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in rela-tion to state of technology, the eco-nomics of improvements in relation to benefits to the public health and safety, and other societal and so-cioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest. Annual limit on intake (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effec-tive dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individ-ual organ or tissue. (ALI values for intake by ingestion and by inhala-tion of selected radionuclides are given in Table 1, Columns 1 and 2, of appendix B to §§20.1001 - 20.2401). Assigned protection factor (APF) means the expected workplace level of respiratory protection that would be provided by a properly function-ing respirator or a class of respira-tors to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne con-centration by the APF. Atmosphere-supplying respirator means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and in-cludes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

Background radiation means ra-diation from cosmic sources; natu-rally occurring radioactive material, including radon (except as a decay product of source or special nuclear material); and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licen-see. ``Background radiation'' does not include radiation from source, byproduct, or special nuclear mate-rials regulated by the Commission. Bioassay (radiobioassay) means the determination of kinds, quanti-ties or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement (in vivo counting) or by analysis and evaluation of materials excreted or removed from the human body. Byproduct material means -- (1) Any radioactive material (ex-cept special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or util-izing special nuclear material; and (2) The tailings or wastes pro-duced by the extraction or concen-tration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extrac-tion operations do not constitute "byproduct material" within this definition. Class (or lung class or inhalation class) means a classification scheme for inhaled material accord-ing to its rate of clearance from the pulmonary region of the lung. Ma-terials are classified as D, W, or Y, which applies to a range of clear-ance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days. Collective dose is the sum of the individual doses received in a given period of time by a specified popu-lation from exposure to a specified source of radiation. Commission means the Nuclear Regulatory Commission or its duly authorized representatives.


Committed dose equivalent (HT,50) means the dose equivalent to or-gans or tissues of reference (T) that will be received from an intake of radioactive material by an individ-ual during the 50-year period fol-lowing the intake. Committed effective dose equiva-lent (HE,50) is the sum of the prod-ucts of the weighting factors applicable to each of the body or-gans or tissues that are irradiated and the committed dose equivalent to these organs or tissues

. Constraint (dose constraint) means a value above which speci-fied licensee actions are required. Controlled area means an area, outside of a restricted area but in-side the site boundary, access to which can be limited by the licen-see for any reason. Critical Group means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any appli-cable set of circumstances. Declared pregnant woman means a woman who has voluntarily in-formed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant. Decommission means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits-- (1) Release of the property for unrestricted use and termination of the license; or (2) Release of the property under restricted conditions and termina-tion of the license. Deep-dose equivalent (Hd), which applies to external whole-body ex-posure, is the dose equivalent at a tissue depth of 1 cm (1000 mg/cm2). Demand respirator means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation. Department means the Depart-ment of Energy established by the Department of Energy Organization Act (Pub. L. 95 - 91, 91 Stat. 565, 42 U.S.C. 7101 et seq.) to the ex-

tent that the Department, or its duly authorized representatives, exercises functions formerly vested in the U.S. Atomic Energy Commis-sion, its Chairman, members, offi-cers, and components and transferred to the U.S. Energy Re-search and Development Admini-stration and to the Administrator thereof pursuant to sections 104 (b), (c), and (d) of the Energy Reor-ganization Act of 1974 (Pub. L. 93 - 438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95 - 91, 91 Stat 565 at 577 - 578, 42 U.S.C. 7151). Derived air concentration (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Table 1, Column 3, of appendix B to §§20.1001 - 20.2401. Derived air concentration-hour (DAC-hour) is the product of the concentration of radioactive mate-rial in air (expressed as a fraction or multiple of the derived air con-centration for each radionuclide) and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to rep-resent one ALI, equivalent to a committed effective dose equivalent of 5 rems (0.05 Sv). Distinguishable from background means that the detectable concen-tration of a radionuclide is statisti-cally different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar mate-rials using adequate measurement technology, survey, and statistical techniques. Disposable respirator means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent ex-haustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breath-ing apparatus (SCBA).

Dose or radiation dose is a ge-neric term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equiva-lent, committed effective dose equivalent, or total effective dose equivalent, as defined in other paragraphs of this section. Dose equivalent (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the rem and sievert (Sv). Dosimetry processor means an individual or organization that processes and evaluates individual monitoring equipment in order to determine the radiation dose deliv-ered to the equipment. Embryo/fetus means the devel-oping human organism from con-ception until the time of birth. Entrance or access point means any location through which an in-dividual could gain access to radia-tion areas or to radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use. Exposure means being exposed to ionizing radiation or to radioac-tive material. External dose means that portion of the dose equivalent received from radiation sources outside the body. Extremity means hand, elbow, arm below the elbow, foot, knee, or leg below the knee. Eye dose equivalent applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2). Filtering facepiece (dust mask) means a negative pressure particu-late respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps. Fit factor means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn. Fit test means the use of a proto-col to qualitatively or quantitatively


evaluate the fit of a respirator on an individual. Generally applicable environ-mental radiation standards means standards issued by the Environ-mental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation ex-posures or levels, or concentrations or quantities of radioactive mate-rial, in the general environment outside the boundaries of locations under the control of persons pos-sessing or using radioactive mate-rial. Government agency means any executive department, commission, independent establishment, corpo-ration wholly or partly owned by the United States of America, which is an instrumentality of the United States, or any board, bureau, divi-sion, service, office, officer, author-ity, administration, or other establishment in the executive branch of the Government. Gray [See §20.1004]. Helmet means a rigid respiratory inlet covering that also provides head protection against impact and penetration. Hood means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso. High radiation area means an area, accessible to individuals, in which radiation levels from radia-tion sources external to the body could result in an individual receiv-ing a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation pene-trates. Individual means any human being. Individual monitoring means -- (1) The assessment of dose equivalent by the use of devices designed to be worn by an individ-ual; (2) The assessment of committed effective dose equivalent by bioas-say (see Bioassay) or by determina-tion of the time-weighted air concentrations to which an indi-vidual has been exposed, i.e., DAC-hours; or (3) The assessment of dose equivalent by the use of survey data.

Individual monitoring devices (individual monitoring equipment) means devices designed to be worn by a single individual for the as-sessment of dose equivalent such as film badges, thermolumines-cence dosimeters (TLDs), pocket ionization chambers, and personal ("lapel") air sampling devices. Internal dose means that portion of the dose equivalent received from radioactive material taken into the body. Lens dose equivalent (LDE) ap-plies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2). License means a license issued under the regulations in parts 30 through 36, 39, 40, 50, 60, 61, 63, 70, or 72 of this chapter. Licensed material means source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general or spe-cific license issued by the Commis-sion. Licensee means a license issued under the regulations in parts 30 through 36, 39, 40, 50, 60, 61, 63, 70, or 72 of this chapter. Limits (dose limits) means the permissible upper bounds of radia-tion doses. Lost or missing licensed material means licensed material whose lo-cation is unknown. It includes ma-terial that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation sys-tem. Loose-fitting facepiece means a respiratory inlet covering that is designed to form a partial seal with the face. Member of the public means any individual except when that indi-vidual is receiving an occupational dose. Minor means an individual less than 18 years of age. Monitoring (radiation monitoring, radiation protection monitoring) means the measurement of radia-tion levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

Negative pressure respirator (tight fitting) means a respirator in which the air pressure inside the facepiece is negative during inhala-tion with respect to the ambient air pressure outside the respirator. Nonstochastic effect means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Ra-diation-induced cataract formation is an example of a nonstochastic effect (also called a deterministic effect). NRC means the Nuclear Regula-tory Commission or its duly author-ized representatives. Occupational dose means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radia-tion, whether in the possession of the licensee or other person. Occu-pational dose does not include dose received from background radia-tion, from any medical administra-tion the individual has received, from exposure to individuals ad-ministered radioactive material and released in accordance with §35.75, from voluntary participation in medical research programs, or as a member of the public. Person means -- (1) Any individual, corporation, partnership, firm, association, trust, estate, public or private insti-tution, group, Government agency other than the Commission or the Department of Energy (except that the Department shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and ac-tivities are subject to the licensing and related regulatory authority of the Commission under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 2201), and section 3(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat. 1842)), any State or any political subdivision of or any political entity within a State, any foreign govern-ment or nation or any political subdivision of any such govern-ment or nation, or other entity; and


(2) Any legal successor, repre-sentative, agent, or agency of the foregoing. Planned special exposure means an infrequent exposure to radia-tion, separate from and in addition to the annual dose limits. Positive pressure respirator means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator. Powered air-purifying respirator (PAPR) means an air-purifying res-pirator that uses a blower to force the ambient air through air-purifying elements to the inlet cov-ering. Pressure demand respirator means a positive pressure atmos-phere-supplying respirator that admits breathing air to the facepiece when the positive pres-sure is reduced inside the facepiece by inhalation. Public dose means the dose re-ceived by a member of the public from exposure to radiation or ra-dioactive material released by a licensee, or to any other source of radiation under the control of a licensee. Public dose does not in-clude occupational dose or doses received from background radia-tion, from any medical administra-tion the individual has received, from exposure to individuals ad-ministered radioactive material and released in accordance with §35.75, or from voluntary participation in medical research programs. Qualitative fit test (QLFT) means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent. Quality Factor (Q) means the modifying factor (listed in tables 1004(b).1 and 1004(b).2 of §20.1004) that is used to derive dose equivalent from absorbed dose. Quantitative fit test (QNFT) means an assessment of the ade-quacy of respirator fit by numeri-cally measuring the amount of leakage into the respirator. Quarter means a period of time equal to one-fourth of the year ob-served by the licensee (approxi-mately 13 consective weeks), providing that the beginning of the first quarter in a year coincides with the starting date of the year

and that no day is omitted or du-plicated in consecutive quarters. Rad (See §20.1004). Radiation (ionizing radiation) means alpha particles, beta parti-cles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capa-ble of producing ions. Radiation, as used in this part, does not include non-ionizing radiation, such as ra-dio- or microwaves, or visible, in-frared, or ultraviolet light. Radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equiva-lent in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates. Reference man means a hypo-thetical aggregation of human physical and physiological charac-teristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standard-ize results of experiments and to relate biological insult to a common base. Rem (See §20.1004). Residual radioactivity means ra-dioactivity in structures, materials, soils, groundwater, and other me-dia at a site resulting from activities under the licensee's control. This includes radioactivity from all li-censed and unlicensed sources used by the licensee, but excludes background radiation. It also in-cludes radioactive materials re-maining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accor-dance with the provisions of 10 CFR part 20. Respiratory protective device means an apparatus, such as a respirator, used to reduce the indi-vidual's intake of airborne radioac-tive materials. Restricted area means an area, access to which is limited by the licensee for the purpose of protect-ing individuals against undue risks from exposure to radiation and ra-dioactive materials. Restricted area does not include areas used as residential quarters, but separate

rooms in a residential building may be set apart as a restricted area. Sanitary sewerage means a sys-tem of public sewers for carrying off waste water and refuse, but exclud-ing sewage treatment facilities, sep-tic tanks, and leach fields owned or operated by the licensee. Self-contained breathing appara-tus (SCBA) means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user. Shallow-dose equivalent (HS), which applies to the external expo-sure of the skin or an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over an area of 1 square centimeter. Sievert (See §20.1004). Site boundary means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee. Source material means -- (1) Uranium or thorium or any combination of uranium and tho-rium in any physical or chemical form; or (2) Ores that contain, by weight, one-twentieth of 1 percent (0.05 percent), or more, of uranium, tho-rium, or any combination of ura-nium and thorium. Source material does not include special nuclear material. Special nuclear material means -- (1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Commis-sion, pursuant to the provisions of section 51 of the Act, determines to be special nuclear material, but does not include source material; or (2) Any material artificially en-riched by any of the foregoing but does not include source material. Stochastic effects means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Heredi-tary effects and cancer incidence are examples of stochastic effects. Supplied-air respirator (SAR) or airline respirator means an atmos-phere-supplying respirator for which the source of breathing air is not designed to be carried by the user.


Survey means an evalulation of the radiological conditions and po-tential hazards incident to the pro-duction, use, transfer, release, disposal, or presence of radioactive material or other sources of radia-tion. When appropriate, such an evaluation includes a physical sur-vey of the location of radioactive material and measurements or cal-culations of levels of radiation, or concentrations or quantities of ra-dioactive material present. Tight-fitting facepiece means a respiratory inlet covering that forms a complete seal with the face. Total Effective Dose Equivalent (TEDE) means the sum of the deep-dose equivalent (for external expo-sures) and the committed effective dose equivalent (for internal expo-sures). Unrestricted area means an area, access to which is neither limited nor controlled by the licensee. Uranium fuel cycle means the operations of milling of uranium ore, chemical conversion of ura-nium, isotopic enrichment of ura-nium, fabrication of uranium fuel, generation of electricity by a light-water-cooled nuclear power plant using uranium fuel, and reprocess-ing of spent uranium fuel to the extent that these activities directly support the production of electrical power for public use. Uranium fuel cycle does not include mining op-erations, operations at waste dis-posal sites, transportation of radioactive material in support of these operations, and the reuse of recovered non-uranium special nu-clear and byproduct materials from the cycle. User seal check (fit check) means an action conducted by the respira-tor user to determine if the respira-tor is properly seated to the face. Examples include negative pressure check, positive pressure check, irri-tant smoke check, or isoamyl ace-tate check. Very high radiation area means an area, accessible to individuals, in which radiation levels from ra-diation sources external to the body could result in an individual receiv-ing an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1 meter from any surface that the radiation penetrates.

(Note: At very high doses re-ceived at high dose rates, units of absorbed dose (e.g., rads and grays) are appropriate, rather than units of dose equivalent (e.g., rems and sieverts)). Week means 7 consecutive days starting on Sunday. Weighting factor WT, for an organ or tissue (T) is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irra-diated uniformly. For calculating the effective dose equivalent,

1 0.30 results from 0.06 for each of 5 "remainder" organs (excluding the skin and the lens of the eye) that receive the highest doses. 2 For the purpose of weighting the external whole body dose (for add-ing it to the internal dose), a single weighting factor, wT=1.0, has been specified. The use of other weight-ing factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued. Whole body means, for purposes of external exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee. Working level (WL) is any combi-nation of short-lived radon daugh-ters (for radon-222: polonium-218, lead-214, bismuth-214, and polo-nium-214; and for radon-220: po-lonium-216, lead-212, bismuth-212, and polonium-212) in 1 liter of air that will result in the ultimate emission of 1.3x105 MeV of poten-tial alpha particle energy. Working level month (WLM) means an exposure to 1 working level for 170 hours (2,000 working hours per year/12 months per year=approximately 170 hours per month).

Year means the period of time beginning in January used to de-termine compliance with the provi-sions of this part. The licensee may change the starting date of the year used to determine compliance by the licensee provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years. [56 FR 23391, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 58 FR 7736, Feb. 9, 1993; 60 FR 36043, July 13, 1995; 60 FR 48625, Sept. 20, 1995; 61 FR 65127, Dec. 10, 1996; 62 FR 4133, Jan. 29, 1997; 62 FR 39807, July 21, 1997] §20.1004 Units of radiation dose. (a) Definitions. As used in this part, the units of radiation dose are: Gray (Gy) is the SI unit of ab-sorbed dose. One gray is equal to an absorbed dose of 1 Joule/kilogram (100 rads). Rad is the special unit of ab-sorbed dose. One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 joule/kilogram (0.01 gray). Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rems is equal to the absorbed dose in rads multiplied by the quality factor (1 rem=0.01 sievert). Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv=100 rems). (b) As used in this part, the quality factors for converting Table 1004(b).1-Quality Factors and Absorbed Dose Equivalencies

Type of radiation

Qual-ity

factor (Q)

Ab-sorbed dose

equal to a unit dose

equiva-lenta

X-, gamma, or beta radia-tion

1 1


Alpha parti-cles, multi-ple-charged particles, fis-sion frag-ments and heavy parti-cles of un-known charge

20 0.05

Neutrons of unknown energy

10 0.1

High-energy protons

10 0.1

aabsorbed dose in rad equal to 1 rem or the absorbed dose in gray equal. (c) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in paragraph (b) of this section, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for pur-poses of the regulations in this part, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient infor-mation exists to estimate the ap-proximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equiva-lent or the appropriate Q value from table 1004(b).2 to convert a measured tissue dose.

a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cyl-inder tissue-equivalent phantom. b Monoenergetic neutrons incident normally on a 30-cm diameter cyl-inder tissue-equivalent phantom.

§20.1005 Units of radioactivity. For the purposes of this part, activity is expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), or their multi-ples, or disintegrations (transfor-mations) per unit of time. (a) One becquerel=1 disintegra-tion per second (s-1). (b) One curie=3.7x1010 disinte-grations per second=3.7x1010 bec-querels=2.22x1012 disintegrations per minute. [56 FR 23391, May 21, 1991; 56 FR 61352, Dec. 3, 1991] §20.1006 Interpretations. Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by an offi-cer or employee of the Commission other than a written interpretation by the General Counsel will be rec-ognized to be binding upon the Commission. §20.1007 Communications. Unless otherwise specified, communications or reports con-cerning the regulations in this part should be addressed to the Execu-tive Director for Operations, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A commu-nication, report, or application may be delivered in person to the Office of the Executive Director for Opera-tions, 11555 Rockville Pike, Rock-ville, MD 20852. §20.1008 Implementation. (a) [Reserved] (b) The applicable section of §§20.1001 - 20.2402 must be used in lieu of requirements in the stan-dards for protection against radia-tion in effect prior to January 1, 1994(1) that are cited in license con-ditions or technical specifications, except as specified in paragraphs (c), (d), and (e) of this section. If the requirements of this part are more restrictive than the existing license condition, then the licensee shall comply with this part unless ex-empted by paragraph (d) of this section. (c) Any existing license condition or technical specification that is more restrictive than a requirement in §§20.1001 - 20.2402 remains in force until there is a technical

specification change, license amendment, or license renewal. (d) If a license condition or technical specification exempted a licensee from a requirement in the standards for protection against radiation in effect prior to January 1, 1994,(1) it continues to exempt a licensee from the corresponding provision of §§20.1001 - 20.2402. (e) If a license condition cites provisions in requirements in the standards for protection against radiation in effect prior to January 1, 1994(1) and there are no corre-sponding provisions in §§20.1001 - 20.2402, then the license condition remains in force until there is a technical specification change, li-cense amendment, or license re-newal that modifies or removes this condition. [59 FR 41643, Aug. 15, 1994] 1. See §§20.1 - 20.602 codified as of January 1, 1993. §20.1009 Reporting, recording, and application requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the in-formation collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Pa-perwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a col-lection of information unless it dis-plays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0014. (b) The approved information collection requirements contained in this part appear in §§20.1003, 20.1101, 20.1202, 20.1203, 20.1204, 20.1206, 20.1208, 20.1301, 20.1302, 20.1403, 20.1404, 20.1406, 20.1501, 20.1601, 20.1703, 20.1901, 20.1902, 20.1904, 20.1905, 20.1906, 20.2002, 20.2004, 20.2006, 20.2102, 20.2103, 20.2104, 20.2105, 20.2106, 20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 20.2205, 20.2206, 20.2301, and appendix G to 10 CFR Part 20. (c) This part contains informa-tion collection requirements in ad-


dition to those approved under the control number specified in para-graph (a) of this section. These in-formation collection requirements and the control numbers under which they are approved are as fol-lows: (1) In §20.2104, NRC Form 4 is approved under control number 3150-0005. (2) In §§20.2106 and 20.2206, NRC Form 5 is approved under control number 3150-0006. (3) In §20.2006 and appendix G to 10 CFR Part 20, NRC Form 540 and 540A is approved under con-trol number 3150-0164. (4) In §20.2006 and appendix G to 10 CFR Part 20, NRC Form 541 and 541A is approved under con-trol number 3150-0166. (5) In §20.2006 and appendix G to 10 CFR Part 20, NRC Form 542 and 542A is approved under con-trol number 3150-0165. [63 FR 50127, Sept. 21, 1998] Subpart B -- Radiation Protection Programs Source: 56 FR 23396, May 21, 1991, unless otherwise noted. §20.1101 Radiation protection programs. (a) Each licensee shall develop, document, and implement a radia-tion protection program commen-surate with the scope and extent of licensed activities and sufficient to ensure compliance with the provi-sions of this part. (See §20.2102 for recordkeeping requirements relat-ing to these programs.) (b) The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection princi-ples to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA). (c) The licensee shall periodically (at least annually) review the radia-tion protection program content and implementation. (d) To implement the ALARA re-quirements of §20.1101 (b), and notwithstanding the requirements in §20.1301 of this part, a con-straint on air emissions of radioac-tive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject

to §50.34a, such that the individual member of the public likely to re-ceive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in §20.2203 and promptly take ap-propriate corrective action to en-sure against recurrence. [56 FR 23396, May 21, 1991, as amended at 61 FR 65127, Dec. 10, 1996] Subpart C -- Occupational Dose Limits Source: 56 FR 23396, May 21, 1991, unless otherwise noted. §20.1201 Occupational dose lim-its for adults. (a) The licensee shall control the occupational dose to individual adults, except for planned special exposures under §20.1206, to the following dose limits. (1) An annual limit, which is the more limiting of -- (i) The total effective dose equiva-lent being equal to 5 rems (0.05 Sv); or (ii) The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems (0.5 Sv). (2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the ex-tremities, which are: (i) A lens dose equivalent of 15 rems (0.15 Sv), and (ii) A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity. (b) Doses received in excess of the annual limits, including doses received during accidents, emer-gencies, and planned special expo-sures, must be subtracted from the limits for planned special exposures that the individual may receive dur-ing the current year (see §20.1206(e)(1)) and during the indi-vidual's lifetime (see §20.1206(e)(2)). (c) The assigned deep-dose equivalent must be for the part of the body receiving the highest ex-posure. The assigned shallow-dose

equivalent must be the dose aver-aged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compli-ance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable. (d) Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in table 1 of appendix B to part 20 and may be used to determine the individ-ual's dose (see §20.2106) and to demonstrate compliance with the occupational dose limits. (e) In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an indi-vidual to 10 milligrams in a week in consideration of chemical toxicity (see footnote 3 of appendix B to part 20). (f) The licensee shall reduce the dose that an individual may be al-lowed to receive in the current year by the amount of occupational dose received while employed by any other person (see §20.2104(e)). [56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] §20.1202 Compliance with re-quirements for summation of external and internal doses. (a) If the licensee is required to monitor under both §§20.1502(a) and (b), the licensee shall demon-strate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under §20.1502(a) or only under §20.1502(b), then summation is not required to demonstrate compli-ance with the dose limits. The li-censee may demonstrate compliance with the requirements for summation of external and in-ternal doses by meeting one of the conditions specified in paragraph (b) of this section and the condi-tions in paragraphs (c) and (d) of this section. (Note: The dose equivalents for the lens of the eye, the skin, and


the extremities are not included in the summation, but are subject to separate limits.) (b) Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equiva-lent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity: (1) The sum of the fractions of the inhalation ALI for each ra-dionuclide, or (2) The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or (3) The sum of the calculated committed effective dose equiva-lents to all significantly irradiated(1) organs or tissues (T) calculated from bioassay data using appropri-ate biological models and expressed as a fraction of the annual limit. (c) Intake by oral ingestion. If the occupationally exposed individual also receives an intake of radionu-clides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee shall account for this intake and include it in dem-onstrating compliance with the lim-its. (d) Intake through wounds or ab-sorption through skin. The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorp-tion. Note: The intake through intact skin has been included in the cal-culation of DAC for hydrogen-3 and does not need to be further evalu-ated. [56 FR 23396, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992] 1 An organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factor, wT, and the committed dose equivalent, HT,50, per unit intake is greater than 10 percent of the maximum weighted value of HT,50, (i.e., wT HT,50) per unit intake for any organ or tissue. §20.1203 Determination of ex-ternal dose from airborne radio-active material. Licensees shall, when determin-ing the dose from airborne radioac-

tive material, include the contribution to the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent from external exposure to the radioactive cloud (see appendix B to part 20, footnotes 1 and 2). Note: Airborne radioactivity measurements and DAC values should not be used as the primary means to assess the deep-dose equivalent when the airborne ra-dioactive material includes ra-dionuclides other than noble gases or if the cloud of airborne radioac-tive material is not relatively uni-form. The determination of the deep-dose equivalent to an individ-ual should be based upon meas-urements using instruments or individual monitoring devices. [56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] §20.1204 Determination of in-ternal exposure. (a) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when re-quired under §20.1502, take suit-able and timely measurements of -- (1) Concentrations of radioactive materials in air in work areas; or (2) Quantities of radionuclides in the body; or (3) Quantities of radionuclides excreted from the body; or (4) Combinations of these meas-urements. (b) Unless respiratory protective equipment is used, as provided in §20.1703, or the assessment of in-take is based on bioassays, the li-censee shall assume that an individual inhales radioactive mate-rial at the airborne concentration in which the individual is present. (c) When specific information on the physical and biochemical prop-erties of the radionuclides taken into the body or the behavior or the material in an individual is known, the licensee may -- (1) Use that information to calcu-late the committed effective dose equivalent, and, if used, the licen-see shall document that informa-tion in the individual's record; and (2) Upon prior approval of the Commission, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of air-

borne radioactive material (e.g., aerosol size distribution or density); and (3) Separately assess the contri-bution of fractional intakes of Class D, W, or Y compounds of a given radionuclide (see appendix B to part 20) to the committed effective dose equivalent. (d) If the licensee chooses to as-sess intakes of Class Y material using the measurements given in §20.1204(a)(2) or (3), the licensee may delay the recording and report-ing of the assessments for periods up to 7 months, unless otherwise required by §§20.2202 or 20.2203, in order to permit the licensee to make additional measurements basic to the assessments. (e) If the identity and concentra-tion of each radionuclide in a mix-ture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours must be either -- (1) The sum of the ratios of the concentration to the appropriate DAC value (e.g., D, W, Y) from ap-pendix B to part 20 for each radio-nuclide in the mixture; or (2) The ratio of the total concen-tration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture. (f) If the identity of each radionu-clide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture must be the most restrictive DAC of any radionuclide in the mixture. (g) When a mixture of radionu-clides in air exists, licensees may disregard certain radionuclides in the mixture if -- (1) The licensee uses the total activity of the mixture in demon-strating compliance with the dose limits in §20.1201 and in comply-ing with the monitoring require-ments in §20.1502(b), and (2) The concentration of any ra-dionuclide disregarded is less than 10 percent of its DAC, and (3) The sum of these percentages for all of the radionuclides disre-garded in the mixture does not ex-ceed 30 percent. (h)(1) In order to calculate the committed effective dose equiva-lent, the licensee may assume that the inhalation of one ALI, or an ex-


posure of 2,000 DAC-hours, results in a committed effective dose equivalent of 5 rems (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent. (2) When the ALI (and the asso-ciated DAC) is determined by the nonstochastic organ dose limit of 50 rems (0.5 Sv), the intake of ra-dionuclides that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) (the stochastic ALI) is listed in parentheses in table 1 of appendix B to part 20. In this case, the licensee may, as a simpli-fying assumption, use the stochas-tic ALIs to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALIs, the licensee must also dem-onstrate that the limit in §20.1201(a)(1)(ii) is met. [56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] 20.1205 [Reserved] §20.1206 Planned special expo-sures. A licensee may authorize an adult worker to receive doses in addition to and accounted for sepa-rately from the doses received un-der the limits specified in §20.1201 provided that each of the following conditions is satisfied -- (a) The licensee authorizes a planned special exposure only in an exceptional situation when alterna-tives that might avoid the dose es-timated to result from the planned special exposure are unavailable or impractical. (b) The licensee (and employer if the employer is not the licensee) specifically authorizes the planned special exposure, in writing, before the exposure occurs. (c) Before a planned special expo-sure, the licensee ensures that the individuals involved are -- (1) Informed of the purpose of the planned operation; (2) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be in-volved in performing the task; and (3) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.

(d) Prior to permitting an individ-ual to participate in a planned spe-cial exposure, the licensee ascertains prior doses as required by §20.2104(b) during the lifetime of the individual for each individual involved. (e) Subject to §20.1201(b), the licensee does not authorize a planned special exposure that would cause an individual to re-ceive a dose from all planned spe-cial exposures and all doses in excess of the limits to exceed -- (1) The numerical values of any of the dose limits in §20.1201(a) in any year; and (2) Five times the annual dose limits in §20.1201(a) during the individual's lifetime. (f) The licensee maintains records of the conduct of a planned special exposure in accordance with §20.2105 and submits a written report in accordance with §20.2204. (g) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures is not to be considered in controlling future occupational dose of the in-dividual under §20.1201(a) but is to be included in evaluations re-quired by §20.1206 (d) and (e). §20.1207 Occupational dose lim-its for minors. The annual occupational dose limits for minors are 10 percent of the annual dose limits specified for adult workers in §20.1201. §20.1208 Dose to an em-bryo/fetus. (a) The licensee shall ensure that the dose equivalent to the em-bryo/fetus during the entire preg-nancy, due to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping require-ments, see §20.2106.) (b) The licensee shall make ef-forts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in para-graph (a) of this section.

(c) The dose equivalent to the embryo/fetus is the sum of-- (1) The deep-dose equivalent to the declared pregnant woman; and (2) The dose equivalent to the embryo/fetus resulting from ra-dionuclides in the embryo/fetus and radionuclides in the declared pregnant woman. (d) If the dose equivalent to the embryo/fetus is found to have ex-ceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the li-censee shall be deemed to be in compliance with paragraph (a) of this section if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the preg-nancy. Subpart D -- Radiation Dose Lim-its for Individual Members of the Public Source: 56 FR 23398, May 21, 1991, unless otherwise noted. §20.1301 Dose limits for individ-ual members of the public. (a) Each licensee shall conduct operations so that-- (1) The total effective dose equivalent to individual members of the public from the licensed opera-tion does not exceed 0.1 rem (1 mil-lisievert) in a year, exclusive of the dose contributions from back-ground radiation, from any medical administration the individual has received, from exposure to indi-viduals administered radioactive material and released in accor-dance with §35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with §20.2003, and (2) The dose in any unrestricted area from external sources, exclu-sive of the dose contributions from patients administered radioactive material and released in accor-dance with §35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour. (b) If the licensee permits mem-bers of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.


(c) A licensee or license applicant may apply for prior NRC authoriza-tion to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). The licensee or license applicant shall include the following informa-tion in this application: (1) Demonstration of the need for and the expected duration of opera-tions in excess of the limit in para-graph (a) of this section; (2) The licensee's program to as-sess and control dose within the 0.5 rem (5 mSv) annual limit; and (3) The procedures to be followed to maintain the dose as low as is reasonably achievable. (d) In addition to the require-ments of this part, a licensee sub-ject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190 shall comply with those stan-dards. (e) The Commission may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in efflu-ents in order to restrict the collec-tive dose. [56 FR 23398, May 21, 1991, as amended at 60 FR 48625, Sept. 20, 1995; 62 FR 4133, Jan. 29, 1997] §20.1302 Compliance with dose limits for individual members of the public. (a) The licensee shall make or cause to be made, as appropriate, surveys of radiation levels in unre-stricted and controlled areas and radioactive materials in effluents released to unrestricted and con-trolled areas to demonstrate com-pliance with the dose limits for individual members of the public in §20.1301. (b) A licensee shall show compli-ance with the annual dose limit in §20.1301 by -- (1) Demonstrating by measure-ment or calculation that the total effective dose equivalent to the in-dividual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or (2) Demonstrating that -- (i) The annual average concen-trations of radioactive material re-leased in gaseous and liquid effluents at the boundary of the

unrestricted area do not exceed the values specified in table 2 of ap-pendix B to part 20; and (ii) If an individual were continu-ously present in an unrestricted area, the dose from external sources would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year. (c) Upon approval from the Commission, the licensee may ad-just the effluent concentration val-ues in appendix B to part 20, table 2, for members of the public, to take into account the actual physi-cal and chemical characteristics of the effluents (e.g., aerosol size dis-tribution, solubility, density, radio-active decay equilibrium, chemical form). [56 FR 23398, May 21, 1991; 56 FR 61352, Dec. 3, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 60 FR 20185, Apr. 25, 1995] Subpart E -- Radiological Criteria for License Termination §20.1401 General provisions and scope. (a) The criteria in this subpart apply to the decommissioning of facilities licensed under parts 30, 40, 50, 60, 61, 63, 70, and 72 of this chapter, as well as other facili-ties subject to the Commission's jurisdiction under the Atomic En-ergy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended. For high-level and low-level waste disposal facili-ties (10 CFR parts 60, 61, and 63), the criteria apply only to ancillary surface facilities that support ra-dioactive waste disposal activities. The criteria do not apply to ura-nium and thorium recovery facili-ties already subject to Appendix A to 10 CFR part 40 or to uranium solution extraction facilities. (b) The criteria in this subpart do not apply to sites which: (1) Have been decommissioned prior to the effective date of the rule in accordance with criteria identi-fied in the Site Decommissioning Management Plan (SDMP) Action Plan of April 16, 1992 (57 FR 13389); (2) Have previously submitted and received Commission approval on a license termination plan (LTP) or decommissioning plan that is

compatible with the SDMP Action Plan criteria; or (3) Submit a sufficient LTP or decommissioning plan before Au-gust 20, 1998 and such LTP or de-commissioning plan is approved by the Commission before August 20, 1999 and in accordance with the criteria identified in the SDMP Ac-tion Plan, except that if an EIS is required in the submittal, there will be a provision for day-for-day ex-tension. (c) After a site has been decom-missioned and the license termi-nated in accordance with the criteria in this subpart, the Com-mission will require additional cleanup only if, based on new in-formation, it determines that the criteria of this subpart were not met and residual radioactivity re-maining at the site could result in significant threat to public health and safety. (d) When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose ex-pected within the first 1000 years after decommissioning. §20.1402 Radiological criteria for unrestricted use A site will be considered accept-able for unrestricted use if the re-sidual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 25 mrem (0.25 mSv) per year, includ-ing that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, ex-pected to potentially result from decontamination and waste dis-posal. §20.1403 Criteria for license ter-mination under restricted condi-tions A site will be considered accept-able for license termination under restricted conditions if: (a) The licensee can demonstrate that further reductions in residual radioactivity necessary to comply


with the provisions of § 20.1402 would result in net public or envi-ronmental harm or were not being made because the residual levels associated with restricted condi-tions are ALARA. Determination of the levels which are ALARA must take into account consideration of any detriments, such as traffic ac-cidents, expected to potentially re-sult from decontamination and waste disposal; (b) The licensee has made provi-sions for legally enforceable institu-tional controls that provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) per year; (c) The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. Acceptable financial assurance mechanisms are-- (1) Funds placed into an account segregated from the licensee's as-sets and outside the licensee's ad-ministrative control as described in § 30.35(f)(1) of this chapter; (2) Surety method, insurance, or other guarantee method as de-scribed in § 30.35(f)(2) of this chap-ter; (3) A statement of intent in the case of Federal, State, or local Gov-ernment licensees, as described in § 30.35(f)(4) of this chapter; or (4) When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such gov-ernmental entity. (d) The licensee has submitted a decommissioning plan or License Termination Plan (LTP) to the Commission indicating the licen-see's intent to decommission in accordance with §§ 30.36(d), 40.42(d), 50.82 (a) and (b), 70.38(d), or 72.54 of this chapter, and specifying that the licensee intends to decommission by re-stricting use of the site. The licen-see shall document in the LTP or decommissioning plan how the ad-vice of individuals and institutions in the community who may be af-fected by the decommissioning has

been sought and incorporated, as appropriate, following analysis of that advice. (1) Licensees proposing to de-commission by restricting use of the site shall seek advice from such affected parties regarding the fol-lowing matters concerning the pro-posed decommissioning-- (i) Whether provisions for institu-tional controls proposed by the li-censee; (A) Will provide reasonable as-surance that the TEDE from resid-ual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) TEDE per year; (B) Will be enforceable; and (C) Will not impose undue bur-dens on the local community or other affected parties. (ii) Whether the licensee has pro-vided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site; (2) In seeking advice on the is-sues identified in § 20.1403(d)(1), the licensee shall provide for: (i) Participation by representa-tives of a broad cross section of community interests who may be affected by the decommissioning; (ii) An opportunity for a compre-hensive, collective discussion on the issues by the participants rep-resented; and (iii) A publicly available summary of the results of all such discus-sions, including a description of the individual viewpoints of the partici-pants on the issues and the extent of agreement and disagreement among the participants on the is-sues; and (e) Residual radioactivity at the site has been reduced so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from re-sidual radioactivity distinguishable from background to the average member of the critical group is as low as reasonably achievable and would not exceed either-- (1) 100 mrem (1 mSv) per year; or (2) 500 mrem (5 mSv) per year provided the licensee--

(i) Demonstrates that further reductions in residual radioactivity necessary to comply with the 100 mrem/y (1 mSv/y) value of para-graph (e)(1) of this section are not technically achievable, would be prohibitively expensive, or would result in net public or environ-mental harm; (ii) Makes provisions for durable institutional controls; (iii) Provides sufficient financial assurance to enable a responsible government entity or independent third party, including a governmen-tal custodian of a site, both to carry out periodic rechecks of the site no less frequently than every 5 years to assure that the institutional con-trols remain in place as necessary to meet the criteria of § 20.1403(b) and to assume and carry out re-sponsibilities for any necessary control and maintenance of those controls. Acceptable financial as-surance mechanisms are those in paragraph (c) of this section. § 20.1404 Alternate criteria for license termination. (a) The Commission may termi-nate a license using alternate crite-ria greater than the dose criterion of §§ 20.1402, 20.1403(b), and 20.1403(d)(1)(i)(A), if the licensee-- (1) Provides assurance that pub-lic health and safety would con-tinue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the 1 mSv/y (100 mrem/y) limit of subpart D, by submitting an analy-sis of possible sources of exposure; (2) Has employed to the extent practical restrictions on site use according to the provisions of § 20.1403 in minimizing exposures at the site; and (3) Reduces doses to ALARA lev-els, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste dis-posal. (4) Has submitted a decommis-sioning plan or License Termination Plan (LTP) to the Commission indi-cating the licensee's intent to de-commission in accordance with §§ 30.36(d), 40.42(d), 50.82 (a) and (b), 70.38(d), or 72.54 of this chap-ter, and specifying that the licensee proposes to decommission by use


of alternate criteria. The licensee shall document in the decommis-sioning plan or LTP how the advice of individuals and institutions in the community who may be af-fected by the decommissioning has been sought and addressed, as ap-propriate, following analysis of that advice. In seeking such advice, the licensee shall provide for: (i) Participation by representa-tives of a broad cross section of community interests who may be affected by the decommissioning; (ii) An opportunity for a compre-hensive, collective discussion on the issues by the participants rep-resented; and (iii) A publicly available summary of the results of all such discus-sions, including a description of the individual viewpoints of the partici-pants on the issues and the extent of agreement and disagreement among the participants on the is-sues. (b) The use of alternate criteria to terminate a license requires the approval of the Commission after consideration of the NRC staff's recommendations that will address any comments provided by the En-vironmental Protection Agency and any public comments submitted pursuant to § 20.1405. § 20.1405 Public notification and public participation. Upon the receipt of an LTP or decommissioning plan from the licensee, or a proposal by the licen-see for release of a site pursuant to §§ 20.1403 or 20.1404, or when-ever the Commission deems such notice to be in the public interest, the Commission shall: (a) Notify and solicit comments from: (1) local and State governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and (2) the Environmental Protection Agency for cases where the licensee proposes to release a site pursuant to § 20.1404. (b) Publish a notice in the Fed-eral Register and in a forum, such as local newspapers, letters to State or local organizations, or other ap-propriate forum, that is readily ac-cessible to individuals in the

vicinity of the site, and solicit comments from affected parties. § 20.1406 Minimization of con-tamination Applicants for licenses, other than renewals, after August 20, 1997, shall describe in the applica-tion how facility design and proce-dures for operation will minimize, to the extent practicable, contami-nation of the facility and the envi-ronment, facilitate eventual decommissioning, and minimize, to the extent practicable, the genera-tion of radioactive waste. Subpart F -- Surveys and Moni-toring Source: 56 FR 23398, May 21, 1991, unless otherwise noted. §20.1501 General. (a) Each licensee shall make or cause to be made, surveys that -- (1) May be necessary for the li-censee to comply with the regula-tions in this part; and (2) Are reasonable under the cir-cumstances to evaluate -- (i) The magnitude and extent of radiation levels; and (ii) Concentrations or quantities of radioactive material; and (iii) The potential radiological hazards. (b) The licensee shall ensure that instruments and equipment used for quantitative radiation meas-urements (e.g., dose rate and efflu-ent monitoring) are calibrated periodically for the radiation meas-ured. (c) All personnel dosimeters (ex-cept for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities) that require processing to determine the radiation dose and that are used by licensees to comply with §20.1201, with other applicable provisions of this chapter, or with conditions specified in a license must be proc-essed and evaluated by a dosimetry processor -- (1) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Ac-creditation Program (NVLAP) of the National Institute of Standards and Technology; and (2) Approved in this accreditation process for the type of radiation or

radiations included in the NVLAP program that most closely ap-proximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored. §20.1502 Conditions requiring individual monitoring of external and internal occupational dose. Each licensee shall monitor ex-posures to radiation and radioac-tive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum -- (a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radia-tion sources under the control of the licensee and shall supply and require the use of individual moni-toring devices by-- (1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in §20.1201(a), (2) Minors likely to receive, in 1 year, from radiation sources exter-nal to the body, a deep dose equiva-lent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv); (3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and (4) Individuals entering a high or very high radiation area. (b) Each licensee shall monitor (see §20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to -- (1) Adults likely to receive, in 1 year, an intake in excess of 10 per-cent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to §§20.1001-20.2402; (2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and (3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).


[56 FR 23398, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] 2 All of the occupational doses in §20.1201 continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded. Subpart G -- Control of Exposure From External Sources in Re-stricted Areas Source: 56 FR 23398, May 21, 1991, unless otherwise noted. §20.1601 Control of access to high radiation areas. (a) The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features -- (1) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep-dose equiva-lent of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates; (2) A control device that ener-gizes a conspicuous visible or audi-ble alarm signal so that the individual entering the high radia-tion area and the supervisor of the activity are made aware of the en-try; or (3) Entryways that are locked, except during periods when access to the areas is required, with posi-tive control over each individual entry. (b) In place of the controls re-quired by paragraph (a) of this sec-tion for a high radiation area, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unau-thorized entry. (c) A licensee may apply to the Commission for approval of alterna-tive methods for controlling access to high radiation areas. (d) The licensee shall establish the controls required by para-graphs (a) and (c) of this section in a way that does not prevent indi-viduals from leaving a high radia-tion area. (e) Control is not required for each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials

prepared for transport and pack-aged and labeled in accordance with the regulations of the Depart-ment of Transportation provided that -- (1) The packages do not remain in the area longer than 3 days; and (2) The dose rate at 1 meter from the external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour. (f) Control of entrance or access to rooms or other areas in hospitals is not required solely because of the presence of patients containing ra-dioactive material, provided that there are personnel in attendance who will take the necessary precau-tions to prevent the exposure of individuals to radiation or radioac-tive material in excess of the limits established in this part and to op-erate within the ALARA provisions of the licensee's radiation protec-tion program. §20.1602 Control of access to very high radiation areas. In addition to the requirements in §20.1601, the licensee shall in-stitute additional measures to en-sure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 grays) or more in 1 hour at 1 meter from a radiation source or any surface through which the ra-diation penetrates. Subpart H -- Respiratory Protec-tion and Controls to Restrict In-ternal Exposure in Restricted Areas Source: 56 FR 23400, May 21, 1991, unless otherwise noted. §20.1701 Use of process or other engineering controls. The licensee shall use, to the extent practical, process or other engineering controls (e.g., contain-ment, decontamination, or ventila-tion) to control the concentration of radioactive material in air. §20.1702 Use of other controls. (a) When it is not practical to apply process or other engineering controls to control the concentra-tions of radioactive material in the air to values below those that de-fine an airborne radioactivity area, the licensee shall, consistent with

maintaining the total effective dose equivalent ALARA, increase moni-toring and limit intakes by one or more of the following means-- (1) Control of access; (2) Limitation of exposure times; (3) Use of respiratory protection equipment; or (4) Other controls. (b) If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiologi-cal factors. The licensee should also consider the impact of respirator use on workers' industrial health and safety. §20.1703 Use of individual respi-ratory protection equipment. If the licensee assigns or per-mits the use of respiratory protec-tion equipment to limit the intake of radioactive material, (a) The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this part. (b) If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the NRC for authorized use of this equip-ment except as provided in this part. The application must include evidence that the material and per-formance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information. (c) The licensee shall implement and maintain a respiratory protec-tion program that includes: (1) Air sampling sufficient to identify the potential hazard, per-mit proper equipment selection, and estimate doses; (2) Surveys and bioassays, as necessary, to evaluate actual in-takes; (3) Testing of respirators for op-erability (user seal check for face sealing devices and functional check for others) immediately prior to each use;


(4) Written procedures regard-ing-- (i) Monitoring, including air sampling and bioassays; (ii) Supervision and training of respirator users; (iii) Fit testing; (iv) Respirator selection; (v) Breathing air quality; (vi) Inventory and control; (vii) Storage, issuance, mainte-nance, repair, testing, and quality assurance of respiratory protection equipment; (viii) Recordkeeping; and (ix) Limitations on periods of respirator use and relief from respi-rator use; (5) Determination by a physician that the individual user is medi-cally fit to use respiratory protec-tion equipment; before (i) The initial fitting of a face sealing respirator; (ii) Before the first field use of non-face sealing respirators, and (iii) Either every 12 months thereafter, or periodically at a fre-quency determined by a physician. (6) Fit testing, with fit factor " 10 times the APF for negative pressure devices, and a fit factor " 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a fre-quency not to exceed 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode. (d) The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication fail-ure, significant deterioration of op-erating conditions, or any other conditions that might require such relief. (e) The licensee shall also con-sider limitations appropriate to the type and mode of use. When select-ing respiratory devices the licensee shall provide for vision correction, adequate communication, low tem-perature work environments, and the concurrent use of other safety or radiological protection equip-ment. The licensee shall use equipment in such a way as not to

interfere with the proper operation of the respirator. (f) Standby rescue persons are required whenever one-piece at-mosphere-supplying suits, or any combination of supplied air respira-tory protection device and person-nel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby per-sons must be equipped with respi-ratory protection devices or other apparatus appropriate for the po-tential hazards. The standby rescue persons shall observe or otherwise maintain continuous communica-tion with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be im-mediately available to assist them in case of a failure of the air supply or for any other reason that re-quires relief from distress. A suffi-cient number of standby rescue persons must be immediately avail-able to assist all users of this type of equipment and to provide effec-tive emergency rescue if needed. (g) Atmosphere-supplying respi-rators must be supplied with res-pirable air of grade D quality or better as defined by the Com-pressed Gas Association in publica-tion G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria in-clude-- (1) Oxygen content (v/v) of 19.5-23.5%; (2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less; (3) Carbon monoxide (CO) con-tent of 10 ppm or less; (4) Carbon dioxide content of 1,000 ppm or less; and (5) Lack of noticable odor. (h) The licensee shall ensure that no objects, materials or sub-stances, such as facial hair, or any conditions that interfere with the face--facepiece seal or valve func-tion, and that are under the control of the respirator wearer, are pre-sent between the skin of the wearer's face and the sealing sur-face of a tight-fitting respirator facepiece.

(i) In estimating the dose to in-dividuals from intake of airborne radioactive materials, the concen-tration of radioactive material in the air that is inhaled when respi-rators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the cor-rected value may be used. §20.1704 Further restrictions on the use of respiratory protection equipment. The Commission may impose restrictions in addition to the provi-sions of §§20.1702, 20.1703, and Appendix A to Part 20, in order to: (a) Ensure that the respiratory protection program of the licensee is adequate to limit doses to indi-viduals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and (b) Limit the extent to which a licensee may use respiratory pro-tection equipment instead of proc-ess or other engineering controls. 7. Section 20.1705 is added to subpart H as follows: §20.1705--Application for use of higher assigned protection fac-tors. The licensee shall obtain au-thorization from the Commission before using assigned protection factors in excess of those specified in Appendix A to Part 20. The Commission may authorize a licen-see to use higher assigned protec-tion factors on receipt of an application that-- (a) Describes the situation for which a need exists for higher pro-tection factors; and (b) Demonstrates that the respi-ratory protection equipment pro-vides these higher protection factors under the proposed condi-tions of use. Subpart I -- Storage and Control of Licensed Material Source: 56 FR 23401, May 21, 1991, unless otherwise noted.


§20.1801 Security of stored ma-terial. The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. §20.1802 Control of material not in storage. The licensee shall control and maintain constant surveillance of licensed material that is in a con-trolled or unrestricted area and that is not in storage. Subpart J -- Precautionary Pro-cedures Source: 56 FR 23401, May 21, 1991, unless otherwise noted. §20.1901 Caution signs. (a) Standard radiation symbol. Unless otherwise authorized by the Commission, the symbol prescribed by this part shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed by this part is the three-bladed design:

(1) Cross-hatched area is to be magenta, or purple, or black, and (2) The background is to be yel-low. (b) Exception to color require-ments for standard radiation sym-bol. Notwithstanding the requirements of paragraph (a) of this section, licensees are author-ized to label sources, source hold-ers, or device components containing sources of licensed ma-terials that are subjected to high temperatures, with conspicuously etched or stamped radiation cau-tion symbols and without a color requirement.

c) Additional information on signs and labels. In addition to the contents of signs and labels pre-scribed in this part, the licensee may provide, on or near the re-quired signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to mini-mize the exposures. §20.1902 Posting requirements. (a) Posting of radiation areas. The licensee shall post each radia-tion area with a conspicuous sign or signs bearing the radiation sym-bol and the words "CAUTION, RADIATION AREA." (b) Posting of high radiation ar-eas. The licensee shall post each high radiation area with a con-spicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA." (c) Posting of very high radiation areas. The licensee shall post each very high radiation area with a con-spicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA." (d) Posting of airborne radioactiv-ity areas. The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA." (e) Posting of areas or rooms in which licensed material is used or stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in appendix C to part 20 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)." [56 FR 23401, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] §20.1903 Exceptions to posting requirements. (a) A licensee is not required to post caution signs in areas or

rooms containing radioactive mate-rials for periods of less than 8 hours, if each of the following con-ditions is met: (1) The materials are constantly attended during these periods by an individual who takes the pre-cautions necessary to prevent the exposure of individuals to radiation or radioactive materials in excess of the limits established in this part; and (2) The area or room is subject to the licensee's control. (b) Rooms or other areas in hos-pitals that are occupied by patients are not required to be posted with caution signs pursuant to §20.1902 provided that the patient could be released from licensee control pur-suant to §35.75 of this chapter. (c) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at 30 centimeters from the surface of the source container or housing does not exceed 0.005 rem (0.05 mSv) per hour. (d) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs under §20.1902 if-- (1) Access to the room is con-trolled pursuant to 10 CFR 35.615; and (2) Personnel in attendance take necessary precautions to prevent the inadvertent exposure of work-ers, other patients, and members of the public to radiation in excess of the limits established in this part. [56 FR 23401, May 21, 1991, as amended at 57 FR 39357, Aug. 31, 1992; 62 FR 4133, Jan. 29, 1997] §20.1904 Labeling containers. (a) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioac-tivity, the date for which the activ-ity is estimated, radiation levels, kinds of materials, and mass en-richment) to permit individuals handling or using the containers,


or working in the vicinity of the containers, to take precautions to avoid or minimize exposures. (b) Each licensee shall, prior to removal or disposal of empty un-contaminated containers to unre-stricted areas, remove or deface the radioactive material label or other-wise clearly indicate that the con-tainer no longer contains radioactive materials.

§20.1905 Exemptions to labeling requirements. A licensee is not required to label -- (a) Containers holding licensed material in quantities less than the quantities listed in appendix C to part 20; or (b) Containers holding licensed material in concentrations less than those specified in table 3 of appendix B to part 20; or (c) Containers attended by an individual who takes the precau-tions necessary to prevent the ex-posure of individuals in excess of the limits established by this part; or (d) Containers when they are in transport and packaged and la-beled in accordance with the regu-lations of the Department of Transportation,(3) or (e) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these in-dividuals by a readily available written record (examples of con-tainers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells). The record must be retained as long as the containers are in use for the purpose indicated on the record; or (f) Installed manufacturing or process equipment, such as reactor components, piping, and tanks. [56 FR 23401, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] 3 Labeling of packages containing radioactive materials is required by the Department of Transportation (DOT) if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by DOT regulations 49 CFR 173.403 (m) and (w) and 173.421 - 424.

§20.1906 Procedures for receiv-ing and opening packages. (a) Each licensee who expects to receive a package containing quan-tities of radioactive material in ex-cess of a Type A quantity, as defined in §71.4 and appendix A to part 71 of this chapter, shall make arrangements to receive -- (1) The package when the carrier offers it for delivery; or (2) Notification of the arrival of the package at the carrier's termi-nal and to take possession of the package expeditiously. (b) Each licensee shall -- (1) Monitor the external surfaces of a labeled(3a) package for radioac-tive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR 71.4; (2) Monitor the external surfaces of a labeled3a package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in §71.4 and appendix A to part 71 of this chapter; and (3) Monitor all packages known to contain radioactive material for radioactive contamination and ra-diation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged. (c) The licensee shall perform the monitoring required by paragraph (b) of this section as soon as practi-cal after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours. (d) The licensee shall immedi-ately notify the final delivery carrier and the NRC Operations Center (301-816-5100), by telephone, when-- (1) Removable radioactive sur-face contamination exceeds the limits of §71.87(i) of this chapter; or (2) External radiation levels ex-ceed the limits of §71.47 of this chapter. (e) Each licensee shall -- (1) Establish, maintain, and re-tain written procedures for safely

opening packages in which radioac-tive material is received; and (2) Ensure that the procedures are followed and that due consid-eration is given to special instruc-tions for the type of package being opened. (f) Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring re-quirements of paragraph (b) of this section, but are not exempt from the survey requirement in para-graph (b) of this section for measur-ing radiation levels that is required to ensure that the source is still properly lodged in its shield. [56 FR 23401, May 21, 1991, as amended at 57 FR 39357, Aug. 31, 1992; 60 FR 20185, Apr. 25, 1995] 3a Labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in U.S. Department of Transportation regulations, 49 CFR 172.403 and 172.436 - 440. Subpart K -- Waste Disposal Source: 56 FR 23403, May 21, 1991, unless otherwise noted. §20.2001 General requirements. (a) A licensee shall dispose of licensed material only -- (1) By transfer to an authorized recipient as provided in § 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of this chapter; (2) By decay in storage; or (3) By release in effluents within the limits in §20.1301; or (4) As authorized under §§20.2002, 20.2003, 20.2004, or §20.2005. (b) A person must be specifically licensed to receive waste containing licensed material from other per-sons for: (1) Treatment prior to disposal; or (2) Treatment or disposal by in-cineration; or (3) Decay in storage; or (4) Disposal at a land disposal facility licensed under part 61 of this chapter; or (5) Disposal at a geologic reposi-tory under part 60 or part 63 of this chapter.


§20.2002 Method for obtaining approval of proposed disposal procedures. A licensee or applicant for a li-cense may apply to the Commission for approval of proposed proce-dures, not otherwise authorized in the regulations in this chapter, to dispose of licensed material gener-ated in the licensee's activities. Each application shall include: (a) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties important to risk evaluation, and the pro-posed manner and conditions of waste disposal; and (b) An analysis and evaluation of pertinent information on the nature of the environment; and (c) The nature and location of other potentially affected licensed and unlicensed facilities; and (d) Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in this part. §20.2003 Disposal by release into sanitary sewerage. (a) A licensee may discharge li-censed material into sanitary sew-erage if each of the following conditions is satisfied: (1) The material is readily soluble (or is readily dispersible biological material) in water; and (2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table 3 of appendix B to part 20; and (3) If more than one radionuclide is released, the following conditions must also be satisfied: (i) The licensee shall determine the fraction of the limit in table 3 of appendix B to part 20 represented by discharges into sanitary sewer-age by dividing the actual monthly average concentration of each ra-dionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table 3 of appendix B to part 20; and (ii) The sum of the fractions for each radionuclide required by paragraph (a)(3)(i) of this section does not exceed unity; and

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sani-tary sewerage system in a year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials com-bined. (b) Excreta from individuals un-dergoing medical diagnosis or ther-apy with radioactive material are not subject to the limitations con-tained in paragraph (a) of this sec-tion. [56 FR 23403, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] §20.2004 Treatment or disposal by incineration. (a) A licensee may treat or dis-pose of licensed material by incin-eration only: (1) As authorized by paragraph (b) of this section; or (2) If the material is in a form and concentration specified in §20.2005; or (3) As specifically approved by the Commission pursuant to §20.2002. (b) (1) Waste oils (petroleum de-rived or synthetic oils used princi-pally as lubricants, coolants, hydraulic or insulating fluids, or metalworking oils) that have been radioactively contaminated in the course of the operation or mainte-nance of a nuclear power reactor licensed under part 50 of this chap-ter may be incinerated on the site where generated provided that the total radioactive effluents from the facility, including the effluents from such incineration, conform to the requirements of appendix I to part 50 of this chapter and the effluent release limits contained in applica-ble license conditions other than effluent limits specifically related to incineration of waste oil. The licen-see shall report any changes or ad-ditions to the information supplied under §§50.34 and 50.34a of this chapter associated with this incin-eration pursuant to §50.71 of this chapter, as appropriate. The licen-see shall also follow the procedures of §50.59 of this chapter with re-spect to such changes to the facility or procedures. (2) Solid residues produced in the process of incinerating waste

oils must be disposed of as pro-vided by §20.2001. (3) The provisions of this section authorize onsite waste oil incinera-tion under the terms of this section and supersede any provision in an individual plant license or technical specification that may be inconsis-tent. [57 FR 57656, Dec. 7, 1992] §20.2005 Disposal of specific wastes. (a) A licensee may dispose of the following licensed material as if it were not radioactive: (1) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; and (2) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire ani-mal. (b) A licensee may not dispose of tissue under paragraph (a)(2) of this section in a manner that would permit its use either as food for humans or as animal feed. (c) The licensee shall maintain records in accordance with §20.2108. §20.2006 Transfer for disposal and manifests. (a) The requirements of this sec-tion and appendix G to 10 CFR Part 20 are designed to-- (1) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee, as defined in this part, who ships low-level waste either directly, or indirectly through a waste collector or waste proces-sor, to a licensed low-level waste land disposal facility (as defined in Part 61 of this chapter); (2) Establish a manifest tracking system; and (3) Supplement existing require-ments concerning transfers and recordkeeping for those wastes. (b) Any licensee shipping radio-active waste intended for ultimate disposal at a licensed land disposal facility must document the infor-mation required on NRC's Uniform Low-Level Radioactive Waste Mani-fest and transfer this recorded manifest information to the in-tended consignee in accordance with appendix G to 10 CFR Part 20.


(c) Each shipment manifest must include a certification by the waste generator as specified in section II of appendix G to 10 CFR Part 20. (d) Each person involved in the transfer for disposal and disposal of waste, including the waste genera-tor, waste collector, waste proces-sor, and disposal facility operator, shall comply with the requirements specified in section III of appendix G to 10 CFR Part 20. [63 FR 50128, Sept. 21, 1998] §20.2007 Compliance with envi-ronmental and health protection regulations. Nothing in this subpart relieves the licensee from complying with other applicable Federal, State, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this subpart. Subpart L -- Records Source: 56 FR 23404, May 21, 1991, unless otherwise noted. §20.2101 General provisions. (a) Each licensee shall use the units: curie, rad, rem, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this part. (b) In the records required by this part, the licensee may record quantities in SI units in parenthe-ses following each of the units specified in paragraph (a) of this section. However, all quantities must be recorded as stated in paragraph (a) of this section. (c) Not withstanding the re-quirements of paragraph (a) of this section, when recording informa-tion on shipment manifests, as re-quired in §20.2006(b), information must be recorded in the Interna-tional System of Units (SI) or in SI and units as specified in paragraph (a) of this section. (d) The licensee shall make a clear distinction among the quanti-ties entered on the records required by this part (e.g., total effective dose equivalent, shallow-dose equivalent, lens dose equivalent, deep-dose equivalent, committed effective dose equivalent). [56 FR 23404, May 21, 1991, as amended at 60 FR 15663, Mar. 27, 1995]

Effective Date Note: At 60 FR 15663, Mar. 27, 1995, in §20.2101, paragraph (b) was redesignated as (c) and a new paragraph (b) was added, effective March 1, 1998. §20.2102 Records of radiation protection programs. (a) Each licensee shall maintain records of the radiation protection program, including: (1) The provisions of the pro-gram; and (2) Audits and other reviews of program content and implementa-tion. (b) The licensee shall retain the records required by paragraph (a)(1) of this section until the Com-mission terminates each pertinent license requiring the record. The licensee shall retain the records required by paragraph (a)(2) of this section for 3 years after the record is made. §20.2103 Records of surveys. (a) Each licensee shall maintain records showing the results of sur-veys and calibrations required by §§20.1501 and 20.1906(b). The li-censee shall retain these records for 3 years after the record is made. (b) The licensee shall retain each of the following records until the Commission terminates each perti-nent license requiring the record: (1) Records of the results of sur-veys to determine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents. This includes those records of results of surveys to de-termine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents re-quired under the standards for pro-tection against radiation in effect prior to January 1, 1994; and (2) Records of the results of measurements and calculations used to determine individual in-takes of radioactive material and used in the assessment of internal dose. This includes those records of the results of measurements and calculations used to determine in-dividual intakes of radioactive ma-terial and used in the assessment of internal dose required under the

standards for protection against radiation in effect prior to January 1, 1994; and (3) Records showing the results of air sampling, surveys, and bioas-says required pursuant to §20.1703(c)(1) and (2). This in-cludes those records showing the results of air sampling, surveys, and bioassays required under the standards for protection against radiation in effect prior to January 1, 1994; and (4) Records of the results of measurements and calculations used to evaluate the release of ra-dioactive effluents to the environ-ment. This includes those records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment required under the standards for protection against radiation in effect prior to January 1, 1994. [56 FR 23404, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995] §20.2104 Determination of prior occupational dose. (a) For each individual who is likely to receive in a year, an occu-pational dose requiring monitoring pursuant to §20.1502 the licensee shall -- (1) Determine the occupational radiation dose received during the current year; and (2) Attempt to obtain the records of cumulative occupational radia-tion dose. (b) Prior to permitting an indi-vidual to participate in a planned special exposure, the licensee shall determine -- (1) The internal and external doses from all previous planned special exposures; and (2) All doses in excess of the lim-its (including doses received during accidents and emergencies) re-ceived during the lifetime of the individual. (c) In complying with the re-quirements of paragraph (a) of this section, a licensee may -- (1) Accept, as a record of the oc-cupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work in-volving radiation exposure, that


discloses the nature and the amount of any occupational dose that the individual may have re-ceived during the current year; (2) Accept, as the record of cu-mulative radiation dose, an up-to-date NRC Form 4, or equivalent, signed by the individual and coun-tersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee); and (3) Obtain reports of the individ-ual's dose equivalent(s) from the most recent employer for work in-volving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee) by telephone, telegram, electronic media, or letter. The li-censee shall request a written veri-fication of the dose data if the authenticity of the transmitted re-port cannot be established. (d) The licensee shall record the exposure history of each individual, as required by paragraph (a) of this section, on NRC Form 4, or other clear and legible record, including all of the information required by NRC Form 4(4). The form or record must show each period in which the individual received occupa-tional exposure to radiation or ra-dioactive material and must be signed by the individual who re-ceived the exposure. For each pe-riod for which the licensee obtains reports, the licensee shall use the dose shown in the report in prepar-ing the NRC Form 4. For any period in which the licensee does not ob-tain a report, the licensee shall place a notation on the NRC Form 4 indicating the periods of time for which data are not available. (e) If the licensee is unable to obtain a complete record of an indi-vidual's current and previously ac-cumulated occupational dose, the licensee shall assume -- (1) In establishing administrative controls under §20.1201(f) for the current year, that the allowable dose limit for the individual is re-duced by 1.25 rems (12.5 mSv) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational ra-diation exposure; and

(2) That the individual is not available for planned special expo-sures. (f) The licensee shall retain the records on NRC Form 4 or equiva-lent until the Commission termi-nates each pertinent license requiring this record. The licensee shall retain records used in prepar-ing NRC Form 4 for 3 years after the record is made. This includes records required under the stan-dards for protection against radia-tion in effect prior to January 1, 1994. [56 FR 23404, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 60 FR 20186, Apr. 25, 1995; 60 FR 36043, July 13, 1995] 4 Licensees are not required to partition historical dose between external dose equivalent(s) and in-ternal committed dose equiva-lent(s). Further, occupational exposure histories obtained and recorded on NRC Form 4 before January 1, 1994, might not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual. §20.2105 Records of planned special exposures. (a) For each use of the provisions of §20.1206 for planned special exposures, the licensee shall main-tain records that describe -- (1) The exceptional circum-stances requiring the use of a planned special exposure; and (2) The name of the management official who authorized the planned special exposure and a copy of the signed authorization; and (3) What actions were necessary; and (4) Why the actions were neces-sary; and (5) How doses were maintained ALARA; and (6) What individual and collective doses were expected to result, and the doses actually received in the planned special exposure. (b) The licensee shall retain the records until the Commission ter-minates each pertinent license re-quiring these records. §20.2106 Records of individual monitoring results. (a) Recordkeeping requirement. Each licensee shall maintain re-

cords of doses received by all indi-viduals for whom monitoring was required pursuant to §20.1502, and records of doses received dur-ing planned special exposures, ac-cidents, and emergency conditions. These records(5) must include, when applicable -- (1) The deep-dose equivalent to the whole body, lens dose equiva-lent, shallow-dose equivalent to the skin, and shallow-dose equivalent to the extremities; (2) The estimated intake of ra-dionuclides (see §20.1202); (3) The committed effective dose equivalent assigned to the intake of radionuclides; (4) The specific information used to assess the committed effective dose equivalent pursuant to §20.1204(a) and (c), and when re-quired by §20.1502; (5) The total effective dose equivalent when required by §20.1202; and (6) The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose. (b) Recordkeeping frequency. The licensee shall make entries of the records specified in paragraph (a) of this section at least annually. (c) Recordkeeping format. The licensee shall maintain the records specified in paragraph (a) of this section on NRC Form 5, in accor-dance with the instructions for NRC Form 5, or in clear and legible records containing all the informa-tion required by NRC Form 5. (d) Privacy protection. The re-cords required under this section should be protected from public disclosure because of their personal privacy nature. These records are protected by most State privacy laws and, when transferred to the NRC, are protected by the Privacy Act of 1974, Public Law 93 - 579, 5 U.S.C. 552a, and the Commission's regulations in 10 CFR part 9. (e) The licensee shall maintain the records of dose to an em-bryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. (f) The licensee shall retain the required form or record until the Commission terminates each perti-


nent license requiring this record. This includes records required un-der the standards for protection against radiation in effect prior to January 1, 1994. [56 FR 23404, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995] 5 Assessments of dose equivalent and records made using units in effect before the licensee's adoption of this part need not be changed.

§20.2107 Records of dose to in-dividual members of the public. (a) Each licensee shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public (see §20.1301). (b) The licensee shall retain the records required by paragraph (a) of this section until the Commission terminates each pertinent license requiring the record. §20.2108 Records of waste dis-posal. (a) Each licensee shall maintain records of the disposal of licensed materials made under §§20.2002, 20.2003, 20.2004, 20.2005, 10 CFR part 61 and disposal by burial in soil, including burials authorized before January 28, 1981.(6) (b) The licensee shall retain the records required by paragraph (a) of this section until the Commission terminates each pertinent license requiring the record. Requirements for disposition of these records, prior to license termination, are located in §§30.51, 40.61, 70.51, and 72.80 for activities licensed under these parts. [56 FR 23404, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995; 61 FR 24673, May 16, 1996] 6 A previous §20.304 permitted burial of small quantities of li-censed materials in soil before January 28, 1981, without specific Commission authorization. 20.2109 [Reserved] §20.2110 Form of records. Each record required by this part must be legible throughout the specified retention period. The re-cord may be the original or a repro-duced copy or a microform provided that the copy or microform is au-thenticated by authorized person-

nel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention pe-riod. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signa-tures. The licensee shall maintain adequate safeguards against tam-pering with and loss of records. Subpart M -- Reports Source: 56 FR 23406, May 21, 1991, unless otherwise noted. §20.2201 Reports of theft or loss of licensed material. (a) Telephone reports. (1) Each licensee shall report by telephone as follows: (i) Immediately after its occur-rence becomes known to the licen-see, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in appendix C to part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unre-stricted areas; or (ii) Within 30 days after the oc-currence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in appendix C to part 20 that is still missing at this time. (2) Reports must be made as fol-lows: (i) Licensees having an installed Emergency Notification System shall make the reports to the NRC Operations Center in accordance with §50.72 of this chapter, and (ii) All other licensees shall make reports by telephone to the NRC Operations Center (301)-816-5100. (b) Written reports. (1) Each li-censee required to make a report under paragraph (a) of this section shall, within 30 days after making the telephone report, make a writ-ten report setting forth the follow-ing information: (i) A description of the licensed material involved, including kind,

quantity, and chemical and physi-cal form; and (ii) A description of the circum-stances under which the loss or theft occurred; and (iii) A statement of disposition, or probable disposition, of the licensed material involved; and (iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unre-stricted areas; and (v) Actions that have been taken, or will be taken, to recover the ma-terial; and (vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material. (2) Reports must be made as fol-lows: (i) For holders of an operating license for a nuclear power plant, the events included in paragraph (b) of this section must be reported in accordance with the procedures described in §50.73(b), (c), (d), (e), and (g) of this chapter and must include the information required in paragraph (b)(1) of this section, and (ii) All other licensees shall make reports to the Administrator of the appropriate NRC Regional Office listed in appendix D to part 20. (c) A duplicate report is not re-quired under paragraph (b) of this section if the licensee is also re-quired to submit a report pursuant to §§30.55(c), 40.64(c), 50.72, 50.73, 70.52, 73.27(b), 73.67(e)(3)(vii), 73.67(g)(3)(iii), 73.71, or §150.19(c) of this chapter. (d) Subsequent to filing the writ-ten report, the licensee shall also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information. (e) The licensee shall prepare any report filed with the Commission pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable part of the report. [56 FR 23406, May 21, 1991, as amended at 58 FR 69220, Dec. 30, 1993; 60 FR 20186, Apr. 25, 1995]


§20.2202 Notification of inci-dents. (a) Immediate notification. Not-withstanding any other require-ments for notification, each licensee shall immediately report any event involving byproduct, source, or special nuclear material possessed by the licensee that may have caused or threatens to cause any of the following conditions -- (1) An individual to receive -- (i) A total effective dose equiva-lent of 25 rems (0.25 Sv) or more; or (ii) A lens dose equivalent of 75 rems (0.75 Sv) or more; or (iii) A shallow-dose equivalent to the skin or extremities of 250 rads (2.5 Gy) or more; or (2) The release of radioactive ma-terial, inside or outside of a re-stricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the annual limit on intake (the provi-sions of this paragraph do not ap-ply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures). (b) Twenty-four hour notification. Each licensee shall, within 24 hours of discovery of the event, re-port any event involving loss of con-trol of licensed material possessed by the licensee that may have caused, or threatens to cause, any of the following conditions: (1) An individual to receive, in a period of 24 hours -- (i) A total effective dose equiva-lent exceeding 5 rems (0.05 Sv); or (ii) A lens dose equivalent ex-ceeding 15 rems (0.15 Sv); or (iii) A shallow-dose equivalent to the skin or extremities exceeding 50 rems (0.5 Sv); or (2) The release of radioactive ma-terial, inside or outside of a re-stricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational annual limit on intake (the provisions of this paragraph do not apply to locations where per-sonnel are not normally stationed during routine operations, such as hot-cells or process enclosures). (c) The licensee shall prepare any report filed with the Commission pursuant to this section so that

names of individuals who have re-ceived exposure to radiation or ra-dioactive material are stated in a separate and detachable part of the report. (d) Reports made by licensees in response to the requirements of this section must be made as fol-lows: (1) Licensees having an installed Emergency Notification System shall make the reports required by paragraphs (a) and (b) of this sec-tion to the NRC Operations Center in accordance with 10 CFR 50.72; and (2) All other licensees shall make the reports required by paragraphs (a) and (b) of this section by tele-phone to the NRC Operations Cen-ter (301) 816-5100. (e) The provisions of this section do not include doses that result from planned special exposures, that are within the limits for planned special exposures, and that are reported under §20.2204. [56 FR 23406, May 21, 1991, as amended at 56 FR 40766, Aug. 16, 1991; 57 FR 57879, Dec. 8, 1992; 59 FR 14086, Mar. 25, 1994] §20.2203 Reports of exposures, radiation levels, and concentra-tions of radioactive material ex-ceeding the constraints or limits. (a) Reportable events. In addition to the notification required by §20.2202, each licensee shall sub-mit a written report within 30 days after learning of any of the following occurrences: (1) Any incident for which notifi-cation is required by §20.2202; or (2) Doses in excess of any of the following: (i) The occupational dose limits for adults in §20.1201; or (ii) The occupational dose limits for a minor in §20.1207; or (iii) The limits for an em-bryo/fetus of a declared pregnant woman in §20.1208; or (iv) The limits for an individual member of the public in §20.1301; or (v) Any applicable limit in the license; or (vi) The ALARA constraints for air emissions established under §20.1101(d); or (3) Levels of radiation or concen-trations of radioactive material in --

(i) A restricted area in excess of any applicable limit in the license; or (ii) An unrestricted area in ex-cess of 10 times any applicable limit set forth in this part or in the license (whether or not involving exposure of any individual in ex-cess of the limits in §20.1301); or (4) For licensees subject to the provisions of EPA's generally appli-cable environmental radiation standards in 40 CFR part 190, lev-els of radiation or releases of radio-active material in excess of those standards, or of license conditions related to those standards. (b) Contents of reports. (1) Each report required by paragraph (a) of this section must describe the ex-tent of exposure of individuals to radiation and radioactive material, including, as appropriate: (i) Estimates of each individual's dose; and (ii) The levels of radiation and concentrations of radioactive mate-rial involved; and (iii) The cause of the elevated exposures, dose rates, or concen-trations; and (iv) Corrective steps taken or planned to ensure against a recur-rence, including the schedule for achieving conformance with appli-cable limits, ALARA constraints, generally applicable environmental standards, and associated license conditions. (2) Each report filed pursuant to paragraph (a) of this section must include for each occupationally overexposed(7) individual: the name, Social Security account number, and date of birth. The report must be prepared so that this informa-tion is stated in a separate and de-tachable part of the report. (c) For holders of an operating license for a nuclear power plant, the occurrences included in para-graph (a) of this section must be reported in accordance with the procedures described in §50.73(b), (c), (d), (e), and (g) of this chapter and must also include the informa-tion required by paragraph (b) of this section. Occurrences reported in accordance with §50.73 of this chapter need not be reported by a duplicate report under paragraph (a) of this section. (d) All licensees, other than those holding an operating license for a


nuclear power plant, who make reports under paragraph (a) of this section shall submit the report in writing to the U.S. Nuclear Regula-tory Commission, Document Con-trol Desk, Washington, DC 20555, with a copy to the appropriate NRC Regional Office listed in appendix D to part 20. [56 FR 23406, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995; 61 FR 65127, Dec. 10, 1996] 7 With respect to the limit for the embryo-fetus (§20.1208), the iden-tifiers should be those of the de-clared pregnant woman. §20.2204 Reports of planned spe-cial exposures. The licensee shall submit a writ-ten report to the Administrator of the appropriate NRC Regional Of-fice listed in appendix D to part 20 within 30 days following any planned special exposure con-ducted in accordance with §20.1206, informing the Commis-sion that a planned special expo-sure was conducted and indicating the date the planned special expo-sure occurred and the information required by §20.2105. [56 FR 23406, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995] §20.2205 Reports to individuals of exceeding dose limits. When a licensee is required, pur-suant to the provisions of §§20.2203, 20.2204, or 20.2206, to report to the Commission any ex-posure of an identified occupation-ally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee shall also provide a copy of the report submitted to the Commission to the individual. This report must be transmitted at a time no later than the transmittal to the Commission. [60 FR 36043, July 13, 1995] §20.2206 Reports of individual monitoring. (a) This section applies to each person licensed by the Commission to -- (1) Operate a nuclear reactor designed to produce electrical or heat energy pursuant to §50.21(b) or §50.22 of this chapter or a test-

ing facility as defined in §50.2 of this chapter; or (2) Possess or use byproduct ma-terial for purposes of radiography pursuant to Parts 30 and 34 of this chapter; or (3) Possess or use at any one time, for purposes of fuel process-ing, fabricating, or reprocessing, special nuclear material in a quan-tity exceeding 5,000 grams of con-tained uranium-235, uranium-233, or plutonium, or any combination thereof pursuant to part 70 of this chapter; or (4) Possess high-level radioactive waste at a geologic repository op-erations area pursuant to part 60 or 63 of this chapter; or (5) Possess spent fuel in an in-dependent spent fuel storage instal-lation (ISFSI) pursuant to part 72 of this chapter; or (6) Receive radioactive waste from other persons for disposal un-der part 61 of this chapter; or (7) Possess or use at any time, for processing or manufacturing for distribution pursuant to parts 30, 32, 33 or 35 of this chapter, by-product material in quantities ex-ceeding any one of the following quantities:

1 The Commission may require as a license condition, or by rule, regulation, or order pursuant to §20.2302, reports from licensees who are licensed to use radionu-clides not on this list, in quantities sufficient to cause comparable ra-diation levels. (b) Each licensee in a category listed in paragraph (a) of this sec-tion shall submit an annual report of the results of individual monitor-ing carried out by the licensee for each individual for whom monitor-ing was required by §20.1502 dur-ing that year. The licensee may include additional data for indi-viduals for whom monitoring was provided but not required. The li-censee shall use Form NRC 5 or electronic media containing all the

information required by Form NRC 5. (c) The licensee shall file the re-port required by §20.2206(b), cover-ing the preceding year, on or before April 30 of each year. The licensee shall submit the report to the REIRS Project Manager, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555. [56 FR 23406, May 21, 1991, as amended at 56 FR 32072, July 15, 1991] Subpart N -- Exemptions and Ad-ditional Requirements Source: 56 FR 23408, May 21, 1991, unless otherwise noted. §20.2301 Applications for ex-emptions. The Commission may, upon appli-cation by a licensee or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it deter-mines the exemption is authorized by law and would not result in un-due hazard to life or property. §20.2302 Additional require-ments. The Commission may, by rule, regulation, or order, impose re-quirements on a licensee, in addi-tion to those established in the regulations in this part, as it deems appropriate or necessary to protect health or to minimize dan-ger to life or property. Subpart O – Enforcement §20.2401 Violations. (a) The Commission may obtain an injunction or other court order to prevent a violation of the provi-sions of -- (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reor-ganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of -- (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107 or 109 of


the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; and (iv) Any term, condition, or limi-tation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under Sec-tion 186 of the Atomic Energy Act of 1954, as amended.

[56 FR 23408, May 21, 1991; 56 FR 61352, Dec. 3, 1991, as amended at 57 FR 55071, Nov. 24, 1992] §20.2402 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted viola-tion of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in §§20.1001 through 20.2402 are issued under one or

more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) this section. (b) The regulations in §§ 20.1001 through 20.2402 that are not is-sued under Sections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 20.1001, 20.1002, 20.1003, 20.1004, 20.1005, 20.1006, 20.1007, 20.1008, 20.1009, 20.1405, 20.1704, 20.1903, 20.1905, 20.2002, 20.2007, 20.2301, 20.2302, 20.2401, and 20.2402. [57 FR 55071, Nov. 24, 1992]

a These assigned protection factors apply only in a respiratory protection program that meets the requirements of this Part. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances


when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances must also comply with Department of Labor regulations. Radioactive contaminants for which the concentration values in Table 1, Column 3 of Appendix B to Part 20 are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentra-tions. Under these circumstances, limitations on occupancy may have to be governed by external dose limits. b Air purifying respirators with APF <100 must be equipped with particulate filters that are at least 95 percent efficient. Air purifying respirators with APF = 100 must be equipped with particulate filters that are at least 99 per-cent efficient. Air purifying respirators with APFs >100 must be equipped with particulate filters that are at least 99.97 percent efficient. c The licensee may apply to the Commission for the use of an APF greater than 1 for sorbent cartridges as protec-tion against airborne radioactive gases and vapors (e.g., radioiodine). d Licensees may permit individuals to use this type of respirator who have not been medically screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized that it is difficult to perform an effective positive or negative pressure pre-use user seal check on this type of device. All other respiratory protection program requirements listed in §20.1703 apply. An assigned protection factor has not been assigned for these devices. However, an APF equal to 10 may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test. e Under-chin type only. No distinction is made in this Appendix between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reus-able disposable). Both types are acceptable so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter me-dium is at least 95 percent efficient and all other requirements of this Part are met. f The assigned protection factors for gases and vapors are not applicable to radioactive contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by ab-sorption through the skin so that an overall protection factor of 3 is appropriate when atmosphere-supplying respi-rators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external (submersion) dose considerations. g No NIOSH approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (i.e., §20.1703). h The licensee should implement institutional controls to assure that these devices are not used in areas immedi-ately dangerous to life or health (IDLH). i This type of respirator may be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure such as skin absorption shall be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device. Appendix B to Part 20 -- Annual Limits on Intake (ALIs) and De-rived Air Concentrations (DACs) of Radionuclides for Occupa-tional Exposure; Effluent Con-centrations; Concentrations for Release to Sewerage Introduction For each radionuclide Table 1 indicates the chemical form which is to be used for selecting the ap-propriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 µm and for three classes (D,W,Y) of radioactive mate-rial, which refer to their retention (approximately days, weeks or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times of less than 10 days for D, for W from 10 to 100 days, and for Y greater than 100 days. The class (D, W, or

Y) given in the column headed "Class" applies only to the inhala-tion ALIs and DACs given in Table 1, columns 2 and 3. Table 2 pro-vides concentration limits for air-borne and liquid effluents released to the general environment. Table 3 provides concentration limits for discharges to sanitary sewer sys-tems. Notation The values in Tables 1, 2, and 3 are presented in the computer "E" notation. In this notation a value of 6E-02 represents a value of 6x10-2 or 0.06, 6E+2 represents 6x102 or 600, and 6E+0 represents 6x100 or 6. Table 1 "Occupational" Note that the columns in Ta-ble 1, of this appendix captioned "Oral Ingestion ALI," "Inhalation ALI," and "DAC," are applicable to

occupational exposure to radioac-tive material. The ALIs in this appendix are the annual intakes of a given radionu-clide by "Reference Man" which would result in either (1) a commit-ted effective dose equivalent of 5 rems (stochastic ALI) or (2) a com-mitted dose equivalent of 50 rems to an organ or tissue (non-stochastic ALI). The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 5 rems. The deriva-tion includes multiplying the com-mitted dose equivalent to an organ or tissue by a weighting factor, wT. This weighting factor is the propor-tion of the risk of stochastic effects resulting from irradiation of the organ or tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of wT are listed under the


definition of weighting factor in §20.1003. The non-stochastic ALIs were derived to avoid non-stochastic effects, such as prompt damage to tissue or reduction in organ function. A value of wT=0.06 is applicable to each of the five organs or tissues in the "remainder" category receiv-ing the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. The following parts of the GI tract -- stomach, small in-testine, upper large intestine, and lower large intestine -- are to be treated as four separate organs. Note that the dose equivalents for extremities (hands and fore-arms, feet and lower legs), skin, and lens of the eye are not consid-ered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. When an ALI is defined by the stochastic dose limit, this value alone, is given. When an ALI is de-termined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochas-tic limit is shown in parentheses. (Abbreviated organ or tissue desig-nations are used: LLI wall = lower large intestine wall; St. wall = stomach wall; Blad wall = bladder wall; and Bone surf = bone sur-face.) The use of the ALIs listed first, the more limiting of the stochastic and non-stochastic ALIs, will en-sure that non-stochastic effects are avoided and that the risk of sto-chastic effects is limited to an ac-ceptably low value. If, in a particular situation involving a ra-dionuclide for which the non-stochastic ALI is limiting, use of that non-stochastic ALI is consid-ered unduly conservative, the licen-see may use the stochastic ALI to determine the committed effective dose equivalent. However, the li-censee shall also ensure that the 50-rem dose equivalent limit for any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the internal committed dose to that organ (not the effective dose). For the case where there is no external dose contribution, this would be demon-strated if the sum of the fractions of

the nonstochastic ALIs (ALIns) that contribute to the committed dose equivalent to the organ receiving the highest dose does not exceed unity (i.e., (intake (in µCi) of each radionuclide/ALIns) <1.0). If there is an external deep dose equivalent contribution of Hd then this sum must be less than l-(Hd/50) instead of being <1.0. The derived air concentration (DAC) values are derived limits in-tended to control chronic occupa-tional exposures. The relationship between the DAC and the ALI is given by: DAC=ALI(in µCi)/(2000 hours per working year x 60 min-utes/hour x 2 x 104 ml per min-ute)=[ALI/2.4x109] µCi/ml, where 2x104 ml is the volume of air breathed per minute at work by "Reference Man" under working conditions of "light work." The DAC values relate to one of two modes of exposure: either ex-ternal submersion or the internal committed dose equivalents result-ing from inhalation of radioactive materials. Derived air concentra-tions based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide sepa-rately. The ALI and DAC values relate to exposure to the single radionuclide named, but also include contribu-tions from the in-growth of any daughter radionuclide produced in the body by the decay of the parent. However, intakes that include both the parent and daughter radionu-clides should be treated by the gen-eral method appropriate for mixtures. The value of ALI and DAC do not apply directly when the individual both ingests and inhales a radionu-clide, when the individual is ex-posed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is ex-posed to both internal and external radiation (see §20.1202). When an individual is exposed to radioactive materials which fall under several of the translocation classifications (i.e., Class D, Class W, or Class Y) of the same radionuclide, the expo-sure may be evaluated as if it were a mixture of different radionuclides. It should be noted that the clas-sification of a compound as Class D, W, or Y is based on the chemical

form of the compound and does not take into account the radiological half-life of different radioisotopes. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionu-clides. Table 2 The columns in Table 2 of this appendix captioned "Effluents," "Air," and "Water," are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of §20.1302. The concentration values given in Columns 1 and 2 of Table 2 are equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the course of a year, would produce a total effective dose equivalent of 0.05 rem (50 millirem or 0.5 mil-lisieverts). Consideration of non-stochastic limits has not been included in de-riving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at the dose levels estab-lished for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupa-tional DAC, the stochastic ALI was used in deriving the corresponding airborne effluent limit in Table 2. For this reason, the DAC and air-borne effluent limits are not always proportional as was the case in ap-pendix B to §§20.1 - 20.601. The air concentration values listed in Table 2, Column 1, were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by 2.4 x 109ml, relating the inhalation ALI to the DAC, as explained above, and then divided by a factor of 300. The fac-tor of 300 includes the following components: a factor of 50 to relate the 5-rem annual occupational dose limit to the 0.1-rem limit for members of the public, a factor of 3 to adjust for the difference in expo-sure time and the inhalation rate for a worker and that for members of the public; and a factor of 2 to adjust the occupational values (de-rived for adults) so that they are applicable to other age groups.


For those radionuclides for which submersion (external dose) is limiting, the occupational DAC in Table 1, Column 3, was divided by 219. The factor of 219 is composed of a factor of 50, as described above, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full-time expo-sure (8,760 hours per year). Note that an additional factor of 2 for age considerations is not warranted in the submersion case. The water concentrations were derived by taking the most restric-tive occupational stochastic oral ingestion ALI and dividing by 7.3 x 107. The factor of 7.3 x 107 (ml) in-cludes the following components: the factors of 50 and 2 described above and a factor of 7.3 x 105 (ml) which is the annual water intake of "Reference Man."

Note 2 of this appendix provides groupings of radionuclides which are applicable to unknown mix-tures of radionuclides. These groupings (including occupational inhalation ALIs and DACs, air and water effluent concentrations and sewerage) require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded either from knowledge of the radionuclide com-position of the source or from ac-tual measurements. Table 3 "Sewer Disposal" The monthly average concentra-tions for release to sanitary sewers are applicable to the provisions in §20.2003. The concentration values

were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 106(ml). The factor of 7.3 x 106(ml) is composed of a factor of 7.3 x 105(ml), the annual water in-take by "Reference Man," and a fac-tor of 10, such that the concentrations, if the sewage re-leased by the licensee were the only source of water ingested by a refer-ence man during a year, would re-sult in a committed effective dose equivalent of 0.5 rem. List of Elements [56 FR 23409, May 21, 1991; 56 FR 61352, Dec. 3, 1991, as amended at 57 FR 57879, Dec. 8, 1992. Redesignated at 58 FR 67659, Dec. 22, 1993]

Footnotes

1E-4 7E-7


Appendix C to Part 20--Quantities(1) of Licensed Mate-rial Requiring Labeling


1The quantities listed above were derived by taking 1/10th of the most restrictive ALI listed in table 1, columns 1 and 2, of appendix B to §§20.1001-20.2401 of this part, rounding to the nearest factor of 10, and arbitrarily constraining the values listed between 0.001 and 1,000 µCi. Values of 100 µCi have been assigned for radionuclides having a radioactive half-life in ex-cess of 109 years (except rhenium, 1000 µCi) to take into account their low specific activity. NOTE: For purposes of §§20.1902(e), 20.1905(a), and 20.2201(a) where there is involved a combination of radionuclides in known amounts, the limit for the combination should be derived as follows: determine, for each ra-dionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the spe-cific radionuclide when not in com-bination. The sum of such ratios for all radionuclides in the combina-tion may not exceed "1" (i.e., "unity"). [56 FR 23465, May 21, 1991; 56 FR 61352, Dec. 3, 1991. Redesig-nated and amended at 58 FR 67659, Dec. 22, 1993; 60 FR 20186, Apr. 25, 1995]


Appendix D to Part 20 -- United States Nuclear Regulatory Com-mission Regional Offices

Appendix E to Part 20 -- [Reserved] Appendix F to Part 20 -- [Reserved] Appendix G to Part 20 -- Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests I. Manifest A waste generator, collector, or processor who transports, or offers for transportation, low-level radio-active waste intended for ultimate disposal at a licensed low-level ra-dioactive waste land disposal facil-ity must prepare a Manifest (OMB Control Numbers 3150 - 0164, - 0165, and - 0166) reflecting infor-mation requested on applicable NRC Forms 540 (Uniform Low-Level Radioactive Waste Manifest (Ship-ping Paper)) and 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description)) and, if necessary, on an applicable NRC Form 542 (Uniform Low-Level Radioactive Waste Manifest (Mani-

fest Index and Regional Compact Tabulation)). NRC Forms 540 and 540A must be completed and must physically accompany the pertinent low-level waste shipment. Upon agreement between shipper and consignee, NRC Forms 541 and 541A and 542 and 542A may be completed, transmitted, and stored in electronic media with the capa-bility for producing legible, accu-rate, and complete records on the respective forms. Licensees are not required by NRC to comply with the manifesting requirements of this part when they ship: (a) LLW for processing and ex-pect its return (i.e., for storage un-der their license) prior to disposal at a licensed land disposal facility; (b) LLW that is being returned to the licensee who is the "waste gen-erator" or "generator," as defined in this part; or (c) Radioactively contaminated material to a "waste processor" that becomes the processor's "residual waste." For guidance in completing these forms, refer to the instruc-tions that accompany the forms. Copies of manifests required by this

appendix may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform mani-fest. NRC Forms 540, 540A, 541, 541A, 542 and 542A, and the ac-companying instructions, in hard copy, may be obtained from the Information and Records Manage-ment Branch, Office of Information Resources Management, U.S. Nu-clear Regulatory Commission, Washington, DC 20555, telephone (301) 415 - 7232. This appendix includes informa-tion requirements of the Depart-ment of Transportation, as codified in 49 CFR part 172. Information on hazardous, medical, or other waste, required to meet Environmental Protection Agency regulations, as codified in 40 CFR parts 259, 261 or elsewhere, is not addressed in this section, and must be provided on the required EPA forms. How-ever, the required EPA forms must accompany the Uniform Low-Level Radioactive Waste Manifest re-quired by this chapter. As used in this appendix, the following definitions apply:


Chelating agent has the same meaning as that given in §61.2 of this chapter. Chemical description means a description of the principal chemi-cal characteristics of a low-level radioactive waste. Computer-readable medium means that the regulatory agency's computer can transfer the informa-tion from the medium into its mem-ory. Consignee means the designated receiver of the shipment of low-level radioactive waste. Decontamination facility means a facility operating under a Com-mission or Agreement State license whose principal purpose is decon-tamination of equipment or materi-als to accomplish recycle, reuse, or other waste management objec-tives, and, for purposes of this part, is not considered to be a consignee for LLW shipments. Disposal container means a con-tainer principally used to confine low-level radioactive waste during disposal operations at a land dis-posal facility (also see "high integ-rity container"). Note that for some shipments, the disposal container may be the transport package. EPA identification number means the number received by a trans-porter following application to the Administrator of EPA as required by 40 CFR part 263. Generator means a licensee op-erating under a Commission or Agreement State license who (1) is a waste generator as defined in this part, or (2) is the licensee to whom waste can be attributed within the context of the Low-Level Radioac-tive Waste Policy Amendments Act of 1985 (e.g., waste generated as a result of decontamination or recycle activities). High integrity container (HIC) means a container commonly de-signed to meet the structural sta-bility requirements of §61.56 of this chapter, and to meet Department of Transportation requirements for a Type A package. Land disposal facility has the same meaning as that given in §61.2 of this chapter. NRC Forms 540, 540A, 541, 541A, 542, and 542A are official NRC Forms referenced in this ap-pendix. Licensees need not use

originals of these NRC Forms as long as any substitute forms are equivalent to the original documen-tation in respect to content, clarity, size, and location of information. Upon agreement between the ship-per and consignee, NRC Forms 541 (and 541A) and NRC Forms 542 (and 542A) may be completed, transmitted, and stored in elec-tronic media. The electronic media must have the capability for pro-ducing legible, accurate, and com-plete records in the format of the uniform manifest. Package means the assembly of components necessary to ensure compliance with the packaging re-quirements of DOT regulations, together with its radioactive con-tents, as presented for transport. Physical description means the items called for on NRC Form 541 to describe a low-level radioactive waste. Residual waste means low-level radioactive waste resulting from processing or decontamination ac-tivities that cannot be easily sepa-rated into distinct batches attributable to specific waste gen-erators. This waste is attributable to the processor or decontamina-tion facility, as applicable. Shipper means the licensed en-tity (i.e., the waste generator, waste collector, or waste processor) who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator. Shipping paper means NRC Form 540 and, if required, NRC Form 540A which includes the in-formation required by DOT in 49 CFR part 172. Source material has the same meaning as that given in §40.4 of this chapter. Special nuclear material has the same meaning as that given in §70.4 of this chapter. Uniform Low-Level Radioactive Waste Manifest or uniform manifest means the combination of NRC Forms 540, 541, and, if necessary, 542, and their respective continua-tion sheets as needed, or equiva-lent. Waste collector means an entity, operating under a Commission or Agreement State license, whose principal purpose is to collect and

consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another li-censed waste collector, licensed waste processor, or licensed land disposal facility. Waste description means the physical, chemical and radiological description of a low-level radioac-tive waste as called for on NRC Form 541. Waste generator means an en-tity, operating under a Commission or Agreement State license, who (1) possesses any material or compo-nent that contains radioactivity or is radioactively contaminated for which the licensee foresees no fur-ther use, and (2) transfers this ma-terial or component to a licensed land disposal facility or to a li-censed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination ser-vices may be a "waste generator" if the transfer of low-level radioactive waste from its facility is defined as "residual waste." Waste processor means an en-tity, operating under a Commission or Agreement State license, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to even-tual transfer of waste to a licensed low-level radioactive waste land disposal facility. Waste type means a waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste sorbed on or solidified in a specifically defined media).

Information Requirements A. General Information The shipper of the radioactive waste, shall provide the following information on the uniform mani-fest: 1. The name, facility address, and telephone number of the licen-see shipping the waste; 2. An explicit declaration indi-cating whether the shipper is acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and


3. The name, address, and tele-phone number, or the name and EPA identification number for the carrier transporting the waste. B. Shipment Information The shipper of the radioactive waste shall provide the following information regarding the waste shipment on the uniform manifest: 1. The date of the waste ship-ment; 2. The total number of pack-ages/disposal containers; 3. The total disposal volume and disposal weight in the shipment; 4. The total radionuclide activity in the shipment; 5. The activity of each of the radionuclides H - 3, C - 14, Tc-99, and I - 129 contained in the ship-ment; and 6. The total masses of U - 233, U - 235, and plutonium in special nuclear material, and the total mass of uranium and thorium in source material. C. Disposal Container and Waste Information The shipper of the radioactive waste shall provide the following information on the uniform mani-fest regarding the waste and each disposal container of waste in the shipment: 1. An alphabetic or numeric identification that uniquely identi-fies each disposal container in the shipment; 2. A physical description of the disposal container, including the manufacturer and model of any high integrity container; 3. The volume displaced by the disposal container; 4. The gross weight of the dis-posal container, including the waste; 5. For waste consigned to a dis-posal facility, the maximum radia-tion level at the surface of each disposal container; 6. A physical and chemical de-scription of the waste; 7. The total weight percentage of chelating agent for any waste con-taining more than 0.1% chelating agent by weight, plus the identity of the principal chelating agent; 8. The approximate volume of waste within a container; 9. The sorbing or solidification media, if any, and the identity of

the solidification media vendor and brand name; 10. The identities and activities of individual radionuclides con-tained in each container, the masses of U - 233, U - 235, and plutonium in special nuclear mate-rial, and the masses of uranium and thorium in source material. For discrete waste types (i.e., acti-vated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization me-dia), the identities and activities of individual radionuclides associated with or contained on these waste types within a disposal container shall be reported; 11. The total radioactivity within each container; and 12. For wastes consigned to a disposal facility, the classification of the waste pursuant to §61.55 of this chapter. Waste not meeting the structural stability requirements of §61.56(b) of this chapter must be identified. D. Uncontainerized Waste Informa-tion The shipper of the radioactive waste shall provide the following information on the uniform mani-fest regarding a waste shipment delivered without a disposal con-tainer: 1. The approximate volume and weight of the waste; 2. A physical and chemical de-scription of the waste; 3. The total weight percentage of chelating agent if the chelating agent exceeds 0.1% by weight, plus the identity of the principal chelat-ing agent; 4. For waste consigned to a dis-posal facility, the classification of the waste pursuant to §61.55 of this chapter. Waste not meeting the structural stability requirements of §61.56(b) of this chapter must be identified; 5. The identities and activities of individual radionuclides contained in the waste, the masses of U - 233, U - 235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material; and 6. For wastes consigned to a disposal facility, the maximum ra-diation levels at the surface of the waste.

E. Multi-Generator Disposal Con-tainer Information This section applies to disposal containers enclosing mixtures of waste originating from different generators. (Note: The origin of the LLW resulting from a processor's activities may be attributable to one or more "generators" (including "waste generators") as defined in this part). It also applies to mix-tures of wastes shipped in an un-containerized form, for which portions of the mixture within the shipment originate from different generators. 1. For homogeneous mixtures of waste, such as incinerator ash, provide the waste description appli-cable to the mixture and the vol-ume of the waste attributed to each generator. 2. For heterogeneous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization me-dia), the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each gen-erator, provide the following: (a) The volume of waste within the disposal container; (b) A physical and chemical de-scription of the waste, including the solidification agent, if any; (c) The total weight percentage of chelating agents for any disposal container containing more than 0.1% chelating agent by weight, plus the identity of the principal chelating agent; (d) The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in 10 CFR 61.56(b); and (e) Radionuclide identities and activities contained in the waste, the masses of U - 233, U - 235, and plutonium in special nuclear mate-rial, and the masses of uranium and thorium in source material if contained in the waste.


II. Certification An authorized representative of the waste generator, processor, or collector shall certify by signing and dating the shipment manifest that the transported materials are properly classified, described, pack-aged, marked, and labeled and are in proper condition for trans-portation according to the applica-ble regulations of the Department of Transportation and the Commis-sion. A collector in signing the cer-tification is certifying that nothing has been done to the collected waste which would invalidate the waste generator's certification. III. Control and Tracking A. Any licensee who transfers radioactive waste to a land disposal facility or a licensed waste collector shall comply with the requirements in paragraphs A.1 through 9 of this section. Any licensee who transfers waste to a licensed waste processor for waste treatment or repackaging shall comply with the requirements of paragraphs A.4 through 9 of this section. A licensee shall: 1. Prepare all wastes so that the waste is classified according to §61.55 and meets the waste char-acteristics requirements in §61.56 of this chapter; 2. Label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste to identify whether it is Class A waste, Class B waste, Class C waste, or greater then Class C waste, in accordance with §61.55 of this chapter; 3. Conduct a quality assurance program to assure compliance with §§61.55 and 61.56 of this chapter (the program must include man-agement evaluation of audits); 4. Prepare the NRC Uniform Low-Level Radioactive Waste Mani-fest as required by this appendix; 5. Forward a copy or electroni-cally transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that ei-ther (i) receipt of the manifest pre-cedes the LLW shipment or (ii) the manifest is delivered to the con-signee with the waste at the time the waste is transferred to the con-signee. Using both (i) and (ii) is also acceptable;

6. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the op-tion chosen in paragraph A.5 of this section; 7. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540; 8. Retain a copy of or electroni-cally store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR Parts 30, 40, and 70 of this chapter; and 9. For any shipments or any part of a shipment for which ac-knowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix. B. Any waste collector licensee who handles only prepackaged waste shall: 1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540; 2. Prepare a new manifest to reflect consolidated shipments that meet the requirements of this ap-pendix. The waste collector shall ensure that, for each container of waste in the shipment, the manifest identifies the generator of that con-tainer of waste; 3. Forward a copy or electroni-cally transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that ei-ther: (i) Receipt of the manifest pre-cedes the LLW shipment or (ii) the manifest is delivered to the con-signee with the waste at the time the waste is transferred to the con-signee. Using both (i) and (ii) is also acceptable; 4. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the op-tion chosen in paragraph B.3 of this section; 5. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540; 6. Retain a copy of or electroni-cally store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer

of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter; 7. For any shipments or any part of a shipment for which ac-knowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix; and 8. Notify the shipper and the Administrator of the nearest Com-mission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled. C. Any licensed waste processor who treats or repackages waste shall: 1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540; 2. Prepare a new manifest that meets the requirements of this ap-pendix. Preparation of the new manifest reflects that the processor is responsible for meeting these requirements. For each container of waste in the shipment, the manifest shall identify the waste generators, the preprocessed waste volume, and the other information as re-quired in paragraph I.E. of this ap-pendix; 3. Prepare all wastes so that the waste is classified according to §61.55 of this chapter and meets the waste characteristics require-ments in §61.56 of this chapter; 4. Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with §§61.55 and 61.57 of this chapter; 5. Conduct a quality assurance program to assure compliance with §§61.55 and 61.56 of this chapter (the program shall include man-agement evaluation of audits); 6. Forward a copy or electroni-cally transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that ei-ther: (i) Receipt of the manifest pre-cedes the LLW shipment or (ii) the manifest is delivered to the con-signee with the waste at the time the waste is transferred to the con-signee. Using both (i) and (ii) is also acceptable;


7. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the op-tion chosen in paragraph C.6 of this section; 8. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540; 9. Retain a copy of or electroni-cally store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter; 10. For any shipment or any part of a shipment for which ac-knowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix; and 11. Notify the shipper and the Administrator of the nearest Com-mission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled. D. The land disposal facility op-erator shall: 1. Acknowledge receipt of the waste within one week of receipt by returning, as a minimum, a signed copy of NRC Form 540 to the ship-per. The shipper to be notified is the licensee who last possessed the waste and transferred the waste to the operator. If any discrepancy exists between materials listed on the Uniform Low-Level Radioactive Waste Manifest and materials re-ceived, copies or electronic transfer of the affected forms must be re-turned indicating the discrepancy; 2. Maintain copies of all com-pleted manifests and electronically store the information required by 10 CFR 61.80(l) until the Commis-sion terminates the license; and 3. Notify the shipper and the Administrator of the nearest Com-mission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

E. Any shipment or part of a shipment for which acknowledge-ment is not received within the times set forth in this section must: 1. Be investigated by the ship-per if the shipper has not received notification or receipt within 20 days after transfer; and 2. Be traced and reported. The investigation shall include tracing the shipment and filing a report with the nearest Commission Re-gional Office listed in Appendix D to this part. Each licensee who con-ducts a trace investigation shall file a written report with the appropri-ate NRC Regional Office within 2 weeks of completion of the investi-gation. [60 FR 15664, Mar. 27, 1995, as amended at 60 FR 25983, May 16, 1995] Effective Date Note: At 60 FR 15664, Mar. 27, 1995, appendix G to part 20 was added, effective March 1, 1998, and at 60 FR 25983, May 16, 1995, III E. was added to appendix G, effective March 1, 1998. PART 21 -- REPORTING OF DEFECTS AND NONCOMPLIANCE

General Provisions

Sec. 21.1 Purpose. 21.2 Scope. 21.3 Definitions. 21.4 Interpretations. 21.5 Communications. 21.6 Posting requirements. 21.7 Exemptions. 21.8 Information collection re-

quirements: OMB approval.

Notification

21.21 Notification of failure to com-ply or existence of a defect and its evaluation.

Procurement Documents

21.31 Procurement documents. Inspections, Records 21.41 Inspections. 21.51 Maintenance and inspection

of records.

Enforcement

21.61 Failure to notify. 21.62 Criminal penalties. Authority: Sec. 161, 68 Stat. 948, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106

Stat. 2951, 2953 (42 U.S.C. 2201, 2282, 2297f); secs. 201, as amended, 206, 88 Stat. 1242, as amended, 1246 (42 U.S.C. 5841, 5846). Section 21.2 also issued under secs. 135, 141, Pub. L. 97 - 425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Source: 42 FR 28893, June 6, 1977, unless otherwise noted.

General Provisions

§21.1 Purpose. The regulations in this part es-tablish procedures and require-ments for implementation of section 206 of the Energy Reorgani-zation Act of 1974. That section requires any individual director or responsible officer of a firm con-structing, owning, operating or supplying the components of any facility or activity which is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended, or the Energy Reorgani-zation Act of 1974, who obtains information reasonably indicating: (a) That the facility, activity or basic component supplied to such facility or activity fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to substantial safety hazards or (b) that the facil-ity, activity, or basic component supplied to such facility or activity contains defects, which could cre-ate a substantial safety hazard, to immediately notify the Commission of such failure to comply or such defect, unless he has actual knowl-edge that the Commission has been adequately informed of such defect or failure to comply. §21.2 Scope. (a) The regulations in this part apply, except as specifically pro-vided otherwise in parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or part 72 of this chapter, to each individual, partnership, corporation, or other entity licensed pursuant to the regulations in this chapter to pos-sess, use, or transfer within the United States source material, by-product material, special nuclear material, and/or spent fuel and high-level radioactive waste, or to construct, manufacture, possess, own, operate, or transfer within the


United States, any production or utilization facility or independent spent fuel storage installation (ISFSI) or monitored retrievable storage installation (MRS); and to each director and responsible offi-cer of such a licensee. The regula-tions in this part apply also to each individual, corporation, partner-ship, or other entity doing business within the United States, and each director and responsible officer of such organization, that constructs a production or utilization facility licensed for the manufacture, con-struction, or operation pursuant to part 50 of this chapter, an ISFSI for the storage of spent fuel licensed pursuant to part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste pur-suant to part 72 of this chapter, or a geologic repository for the dis-posal of high-level radioactive waste under part 60 or 63 of this chapter; or supplies basic components for a facility or activity licensed, other than for export, under parts 30, 40, 50, 60, 61, 63, 70, 71, or part 72 of this chapter. (b) For persons licensed to con-struct a facility under a construc-tion permit issued under §50.23 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under §50.55(e) of this chapter satisfies each person's evaluation, notification, and report-ing obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974. (c) For persons licensed to oper-ate a nuclear power plant under part 50 of this chapter, evaluation of potential defects and appropriate reporting of defects under §§50.72, 50.73 or §73.71 of this chapter sat-isfies each person's evaluation, no-tification, and reporting obligation to report defects under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974. (d) Nothing in these regulations should be deemed to preclude ei-ther an individual, a manufacturer, or a supplier of a commercial grade

item (as defined in §21.3) not sub-ject to the regulations in this part from reporting to the Commission, a known or suspected defect or failure to comply and, as author-ized by law, the identity of anyone so reporting will be withheld from disclosure. NRC regional offices and headquarters will accept collect telephone calls from individuals who wish to speak to NRC repre-sentatives concerning nuclear safety-related problems. The loca-tion and telephone numbers of the four regions (answered during regu-lar working hours), are listed in appendix D to part 20 of this chap-ter. The telephone number of the NRC Operations Center (answered 24 hours a day -- including holi-days) is (301) 816 - 5100. (e) The regulations in this part apply in accordance with 10 CFR 76.60 to each individual, partner-ship, corporation, or other entity required to obtain a certificate of compliance or an approved compli-ance plan under part 76 of this chapter. [56 FR 36089, July 31, 1991, as amended at 59 FR 14086, Mar. 25, 1994; 59 FR 48959, Sept. 23, 1994; 60 FR 48373, Sept. 19, 1995] §21.3 Definitions. As used in this part: Basic component. (1)(i) When applied to nuclear power plants licensed pursuant to 10 CFR Part 30, 40, 50, 60, of this chapter, ba-sic component means a structure, system, or component, or part thereof that affects its safety func-tion necessary to assure: (A) The integrity of the reactor coolant pressure boundary; (B) The capability to shut down the reactor and maintain it in a safe shutdown condition; or (C) The capability to prevent or mitigate the consequences of acci-dents which could result in poten-tial offsite exposures comparable to those referred to in §50.34(a)(1), §50.67(b)(2), or §100.11 of this chapter, as applicable. (ii) Basic components are items designed and manufactured under a quality assurance program com-plying with 10 CFR Part 50, appen-dix B, or commercial grade items which have successfully completed the dedication process.

(2) When applied to other facili-ties and when applied to other ac-tivities licensed pursuant to 10 CFR Parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic component means a structure, sys-tem, or component, or part thereof that affects their safety function, that is directly procured by the li-censee of a facility or activity sub-ject to the regulations in this part and in which a defect or failure to comply with any applicable regula-tion in this chapter, order, or li-cense issued by the Commission could create a substantial safety hazard. (3) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabri-cation, replacement of parts, or consulting services that are associ-ated with the component hardware whether these services are per-formed by the component supplier or others. Commercial grade item. (1) When applied to nuclear power plants licensed pursuant to 10 CFR Part 30, 40, 50, 60, commercial grade item means a structure, system, or component, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufactur-ing process require in-process in-spections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical character-istics of the item cannot be veri-fied). (2) When applied to facilities and activities licensed pursuant to 10 CFR Parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, commercial grade item means an item that is: (i) Not subject to design or specification requirements that are unique to those facilities or activi-ties; (ii) Used in applications other than those facilities or activities; and (iii) To be ordered from the manufacturer/supplier on the ba-sis of specifications set forth in the manufacturer's published product description (for example, a catalog).


Commission means the Nuclear Regulatory Commission or its duly authorized representatives. Constructing or construction means the analysis, design, manu-facture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to the regulations in this part and con-sulting services related to the facil-ity or activity that are safety related. Critical characteristics. When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, critical characteristics are those important design, material, and performance characteristics of a commercial grade item that, once verified, will provide reasonable assurance that the item will per-form its intended safety function. Dedicating entity. When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, dedi-cating entity means the organiza-tion that performs the dedication process. Dedication may be per-formed by the manufacturer of the item, a third-party dedicating en-tity, or the licensee itself. The dedi-cating entity, pursuant to §21.21(c) of this part, is responsible for iden-tifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintaining auditable records of the dedication process. Dedication. (1) When applied to nuclear power plants licensed pur-suant to 10 CFR Part 30, 40, 50, 60, dedication is an acceptance process undertaken to provide rea-sonable assurance that a commer-cial grade item to be used as a basic component will perform its intended safety function and, in this respect, is deemed equivalent to an item designed and manufac-tured under a 10 CFR Part 50, ap-pendix B, quality assurance program. This assurance is achieved by identifying the critical characteristics of the item and veri-fying their acceptability by inspec-tions, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commer-cial grade surveys; product inspec-tions or witness at holdpoints at the manufacturer's facility, and

analysis of historical records for acceptable performance. In all cases, the dedication process must be conducted in accordance with the applicable provisions of 10 CFR Part 50, appendix B. The process is considered complete when the item is designated for use as a basic component. (2) When applied to facilities and activities licensed pursuant to 10 CFR Parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, dedication occurs after receipt when that item is des-ignated for use as a basic compo-nent. Defect means: (1) A deviation in a basic com-ponent delivered to a purchaser for use in a facility or an activity sub-ject to the regulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or (2) The installation, use, or op-eration of a basic component con-taining a defect as defined in this section; or (3) A deviation in a portion of a facility subject to the construction permit or manufacturing licensing requirements of part 50 of this chapter provided the deviation could, on the basis of an evalua-tion, create a substantial safety hazard and the portion of the facil-ity containing the deviation has been offered to the purchaser for acceptance; or (4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued pursuant to part 50 of this chapter. Deviation means a departure from the technical requirements included in a procurement docu-ment. Director means an individual, appointed or elected according to law, who is authorized to manage and direct the affairs of a corpora-tion, partnership or other entity. In the case of an individual proprie-torship, director means the indi-vidual. Discovery means the completion of the documentation first identify-ing the existence of a deviation or failure to comply potentially associ-ated with a substantial safety haz-

ard within the evaluation procedures discussed in §21.21. (a). Evaluation means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard. Notification means the tele-phonic communication to the NRC Operations Center or written transmittal of information to the NRC Document Control Desk. Operating or operation means the operation of a facility or the conduct of a licensed activity which is subject to the regulations in this part and consulting services related to operations that are safety re-lated. Procurement document means a contract that defines the require-ments which facilities or basic com-ponents must meet in order to be considered acceptable by the pur-chaser. Responsible officer means the president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this part. Substantial safety hazard means a loss of safety function to the extent that there is a major re-duction in the degree of protection provided to public health and safety for any facility or activity licensed, other than for export, pursuant to parts 30, 40, 50, 60, 61, 63, 70, 71, or 72 of this chapter. Supplying or supplies means contractually responsible for a ba-sic component used or to be used in a facility or activity which is sub-ject to the regulations in this part. [42 FR 28893, June 6, 1977; 42 FR 36803, July 18, 1977, as amended at 43 FR 48622, Oct. 19, 1978; 46 FR 58283, Dec. 1, 1981; 47 FR 57480, Dec. 27, 1982; 56 FR 36089, July 31, 1991; 59 FR 5519, Feb. 7, 1994; 60 FR 48373, Sept. 19, 1995; 61 FR 65171, Dec. 11, 1996] §21.4 Interpretations. Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any offi-cer or employee of the Commission


other than a written interpretation by the General Counsel will be rec-ognized to be binding upon the Commission. §21.5 Communications. Except where otherwise specified in this part, all written communica-tions and reports concerning the regulations in this part must be addressed to the Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555. In the case of a licensee, a copy must also be sent to the ap-propriate Regional Administrator at the address specified in appendix D to part 20 of this chapter. [56 FR 36089, July 31, 1991] §21.6 Posting requirements. (a)(1) Each individual, partner-ship, corporation, dedicating entity, or other entity subject to the regu-lations in this part shall post cur-rent copies of -- (i) The regulations in this part; (ii) Section 206 of the Energy Reorganization Act of 1974; and (iii) Procedures adopted pursu-ant to the regulations in this part. (2) These documents must be posted in a conspicuous position on any premises within the United States where the activities subject to this part are conducted. (b) If posting of the regulations in this part or the procedures adopted pursuant to the regula-tions in this part is not practicable, the licensee or firm subject to the regulations in this part may, in ad-dition to posting section 206, post a notice which describes the regula-tions/procedures, including the name of the individual to whom reports may be made, and states where they may be examined. (c) The effective date of this sec-tion has been deferred until Janu-ary 6, 1978. [42 FR 28893, June 6, 1977, as amended at 60 FR 48374, Sept. 19, 1995] §21.7 Exemptions. The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the require-ments of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense

and security and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this part to the extent that they supply com-mercial grade items. [42 FR 28893, June 6, 1977, as amended at 43 FR 48622, Oct. 19, 1978] §21.8 Information collection re-quirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the in-formation collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Pa-perwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a col-lection of information unless it dis-plays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0035. (b) The approved information collection requirements contained in this part appear in §§21.7, 21.21, and 21.51. [62 FR 52185, Oct. 6, 1997]

Notification

§21.21 Notification of failure to comply or existence of a defect and its evaluation. (a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regula-tions in this part shall adopt ap-propriate procedures to -- (1) Evaluate deviations and fail-ures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (a)(2) of this section, in all cases within 60 days of discovery, in order to identify a reportable defect or failure to com-ply that could create a substantial safety hazard, were it to remain uncorrected, and (2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply, an interim re-port is prepared and submitted to the Commission through a director

or responsible officer or designated person as discussed in §21.21(c)(5). The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply. (3) Ensure that a director or responsible officer subject to the regulations of this part is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in §21.21(a)(1) or §21.21(a)(2) if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity -- (i) Fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to a substan-tial safety hazard, or (ii) Contains a defect. (b) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to per-form the evaluation to determine if a defect exists, then the supplier must inform the purchasers or af-fected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or fail-ure to comply, pursuant to §21.21(a). (c) A dedicating entity is respon-sible for -- (1) Identifying and evaluating deviations and reporting defects and failures to comply associated with substantial safety hazards for dedicated items; and (2) Maintaining auditable re-cords for the dedication process. (d)(1) A director or responsible officer subject to the regulations of this part or a person designated under §21.21(c)(5) must notify the Commission when he or she ob-tains information reasonably indi-cating a failure to comply or a defect affecting -- (i) The construction or operation of a facility or an activity within the United States that is subject to the licensing requirements under parts


30, 40, 50, 60, 61, 63, 70, 71, or 72 of this chapter and that is within his or her organization's responsi-bility; or (ii) A basic component that is within his or her organization's re-sponsibility and is supplied for a facility or an activity within the United States that is subject to the licensing requirements under parts 30, 40, 50, 60, 61, 63, 70, 71, or 72 of this chapter. (2) The notification to NRC of a failure to comply or of a defect un-der paragraph (c)(1) of this section and the evaluation of a failure to comply or a defect under para-graphs (a)(1) and (a)(2) of this sec-tion, are not required if the director or responsible officer has actual knowledge that the Commission has been notified in writing of the defect or the failure to comply. (3) Notification required by para-graph (c)(1) of this section must be made as follows -- (i) Initial notification by facsim-ile, which is the preferred method of notification, to the NRC Opera-tions Center at (301) 816 - 5151 or by telephone at (301) 816 - 5100 within two days following receipt of information by the director or re-sponsible corporate officer under paragraph (a)(1) of this section, on the identification of a defect or a failure to comply. Verification that the facsimile has been received should be made by calling the NRC Operations Center. This paragraph does not apply to interim reports described in §21.21(a)(2). (ii) Written notification to the NRC at the address specified in §21.5 within 30 days following re-ceipt of information by the director or responsible corporate officer un-der paragraph (a)(3) of this section, on the identification of a defect or a failure to comply. (4) The written report required by this paragraph shall include, but need not be limited to, the fol-lowing information, to the extent known: (i) Name and address of the in-dividual or individuals informing the Commission. (ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.

(iii) Identification of the firm constructing the facility or supply-ing the basic component which fails to comply or contains a defect. (iv) Nature of the defect or fail-ure to comply and the safety haz-ard which is created or could be created by such defect or failure to comply. (v) The date on which the infor-mation of such defect or failure to comply was obtained. (vi) In the case of a basic com-ponent which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being sup-plied for one or more facilities or activities subject to the regulations in this part. (vii) The corrective action which has been, is being, or will be taken; the name of the individual or or-ganization responsible for the ac-tion; and the length of time that has been or will be taken to com-plete the action. (viii) Any advice related to the defect or failure to comply about the facility, activity, or basic com-ponent that has been, is being, or will be given to purchasers or licen-sees. (5) The director or responsible officer may authorize an individual to provide the notification required by this paragraph, provided that, this shall not relieve the director or responsible officer of his or her re-sponsibility under this paragraph. (e) Individuals subject to this part may be required by the Com-mission to supply additional infor-mation related to a defect or failure to comply. Commission action to obtain additional information may be based on reports of defects from other reporting entities. [42 FR 28893, June 6, 1977, as amended at 46 FR 58283, Dec. 1, 1981; 47 FR 57480, Dec. 27, 1982; 52 FR 31611, Aug. 21, 1987; 56 FR 36089, July 31, 1991; 59 FR 14086, Mar. 25, 1994; 60 FR 48374, Sept. 19, 1995]

Procurement Documents

§21.31 Procurement documents. Each individual, corporation, partnership, dedicating entity, or other entity subject to the regula-tions in this part shall ensure that each procurement document for a facility, or a basic component is-

sued by him, her or it on or after January 6, 1978, specifies, when applicable, that the provisions of 10 CFR Part 21 apply. [60 FR 48374, Sept. 19, 1995]

Inspections, Records

§21.41 Inspections. Each individual, corporation, partnership, dedicating entity, or other entity subject to the regula-tions in this part shall permit the Commission to inspect records, premises, activities, and basic components as necessary to ac-complish the purposes of this part. [60 FR 48374, Sept. 19, 1995] §21.51 Maintenance and inspec-tion of records. (a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regula-tions in this part shall prepare and maintain records necessary to ac-complish the purposes of this part, specifically -- (1) Retain evaluations of all de-viations and failures to comply for a minimum of five years after the date of the evaluation; (2) Suppliers of basic compo-nents must retain any notifications sent to purchasers and affected licensees for a minimum of five years after the date of the notifica-tion. (3) Suppliers of basic compo-nents must retain a record of the purchasers of basic components for 10 years after delivery of the basic component or service associated with a basic component. (b) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regula-tions in this part shall permit the Commission the opportunity to in-spect records pertaining to basic components that relate to the iden-tification and evaluation of devia-tions, and the reporting of defects and failures to comply, including any advice given to purchasers or licensees on the placement, erec-tion, installation, operation, main-tenance, modification, or inspection of a basic component. [56 FR 36090, July 31, 1991, as amended at 60 FR 48374, Sept. 19, 1995]


Enforcement

§21.61 Failure to notify. (a) Any director or responsible officer of an entity (including dedi-cating entity) that is not otherwise subject to the deliberate miscon-duct provisions of this chapter but is subject to the regulations in this part who knowingly and con-sciously fails to provide the notice required as by §21.21 shall be sub-ject to a civil penalty equal to the amount provided by section 234 of the Atomic Energy Act of 1954, as amended. (b) Any NRC licensee subject to the regulations in this part who fails to provide the notice required by §21.21 or otherwise fails to comply with the applicable re-quirements of this part shall be subject to a civil penalty as pro-vided by section 234 of the Atomic Energy Act of 1954, as amended. (c) The dedicating entity, pursu-ant to §21.21(c) of this part, is re-sponsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintain-ing auditable records of the dedica-tion process. NRC enforcement action can be taken for failure to identify and evaluate deviations, failure to report defects and failures to comply, or failure to maintain auditable records. [60 FR 48374, Sept. 19, 1995] §21.62 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted viola-tion of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 21 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 21 that are not issued under sections 161b, 161i, or 161o for the pur-poses of section 223 are as follows: §§21.1, 21.2, 21.3, 21.4 21.5, 21.7, 21.8, 21.61, and 21.62. [57 FR 55071, Nov. 24, 1992] PART 30 -- RULES OF GENERAL APPLICABILITY TO DOMESTIC

LICENSING OF BYPRODUCT MATERIAL

General Provisions 30.1 Scope. 30.2 Resolution of conflict. 30.3 Activities requiring license. 30.4 Definitions. 30.5 Interpretations. 30.6 Communications. 30.7 Employee protection. 30.8 Information collection re-

quirements: OMB approval. 30.9 Completeness and accuracy of

information. 30.10 Deliberate misconduct.

Exemptions 30.11 Specific exemptions. 30.12 Persons using byproduct ma-

terial under certain Department of Energy and Nuclear Regulatory Commission contracts.

30.13 Carriers. 30.14 Exempt concentrations. 30.15 Certain items containing by-

product material. 30.16 Resins containing scandium-

46 and designed for sand-consolidation in oil wells.

30.18 Exempt quantities. 30.19 Self-luminous products con-

taining tritium, krypton-85, or promethium-147.

30.20 Gas and aerosol detectors containing byproduct material.

30.21 Radioactive drug: Capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.

Licenses

30.31 Types of licenses. 30.32 Application for specific li-

censes. 30.33 General requirements for

issuance of specific licenses. 30.34 Terms and conditions of li-

censes. 30.35 Financial assurance and re-

cordkeeping for decommission-ing.

30.36 Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.

30.37 Application for renewal of licenses.

30.38 Application for amendment of licenses.

30.39 Commission action on appli-cations to renew or amend.

30.41 Transfer of byproduct mate-rial.

Records, Inspections, Tests, and Reports

30.50 Reporting requirements. 30.51 Records. 30.52 Inspections. 30.53 Tests. 30.55 Tritium reports.

Enforcement

30.61 Modification and revocation of licenses.

30.62 Right to cause the withhold-ing or recall of byproduct mate-rial.

30.63 Violations. 30.64 Criminal penalties.

Schedules

30.70 Schedule A -- exempt con-centrations.

30.71 Schedule B. 30.72 Schedule C -- Quantities of

radioactive materials requiring consideration of the need for an emergency plan for responding to a release.

Appendix A to Part 30 -- Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assur-ance of Funds for Decommission-ing

Appendix B to Part 30 -- Quantities of Licensed Material Requiring Labeling

Appendix C to Part 30 -- Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning

Appendix D to Part 30--Criteria Relating To Use of Financial Tests and Self-Guarantee for Providing Reasonable Assurance of Funds for Decommissioning by Com-mercial Companies That Have no Outstanding Rated Bonds

Appendix E to Part 30--Criteria Re-lating to Use of Financial Tests and Self-Guarantee For Providing Reasonable Assurance of Funds For Decommissioning by Non-profit Colleges, Universities, and Hospitals

Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83, Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201 as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).


Section 30.7 also issued under Pub. L. 95 - 601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102 - 486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

General Provisions

§30.1 Scope. This part prescribes rules appli-cable to all persons in the United States governing domestic licensing of byproduct material under the Atomic Energy Act of 1954, as amended (68 Stat. 919), and under title II of the Energy Reorganization Act of 1974 (88 Stat. 1242), and exemptions from the domestic li-censing requirements permitted by Section 81 of the Act. This part also gives notice to all persons who knowingly provide to any licensee, applicant, certificate of registration holder, contractor, or subcontrac-tor, components, equipment, mate-rials, or other goods or services, that relate to a licensee's, appli-cant's or certificate of registration holder's activities subject to this part, that they may be individually subject to NRC enforcement action for violation of §30.10. [56 FR 40689, Aug. 15, 1991] §30.2 Resolution of conflict. The requirements of this part are in addition to, and not in sub-stitution for, other requirements of this chapter. In any conflict be-tween the requirements in this part and a specific requirement in an-other part of the regulations in this chapter, the specific requirement governs. [30 FR 8185, June 26, 1965] §30.3 Activities requiring li-cense. Except for persons exempt as provided in this part and part 150 of this chapter, no person shall manufacture, produce, transfer, receive, acquire, own, possess, or use byproduct material except as authorized in a specific or general license issued pursuant to the regulations in this chapter. [30 FR 8185, June 26, 1965, as amended at 43 FR 6921, Feb. 17, 1978]

§30.4 Definitions. Act means the Atomic Energy Act of 1954 (68 Stat. 919), includ-ing any amendments thereto; Agreement State means any state with which the Atomic Energy Commission or the Nuclear Regula-tory Commission has entered into an effective agreement under sub-section 274b. of the Act. Non-agreement State means any other State; Alert means events may occur, are in progress, or have occurred that could lead to a release of ra-dioactive material but that the re-lease is not expected to require a response by offsite response or-ganizations to protect persons off-site. By product material means any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the proc-ess of producing or utilizing special nuclear material; Commencement of construction means any clearing of land, excava-tion, or other substantial action that would adversely affect the natural environment of a site but does not include changes desirable for the temporary use of the land for public recreational uses, neces-sary borings to determine site characteristics or other precon-struction monitoring to establish background information related to the suitability of a site or to the protection of environmental values. Commission means the Nuclear Regulatory Commission and its duly authorized representatives; Curie means that amount of radioactive material which disinte-grates at the rate of 37 billion at-oms per second; Decommission means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits-- (1) Release of the property for unrestricted use and termination of the license; or (2) Release of the property under restricted conditions and termina-tion of the license. Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

Department and Department of Energy means the Department of Energy established by the Depart-ment of Energy Organization Act (Pub. L. 95 - 91, 91 Stat. 565, 42 U.S.C. 7101 et seq.) to the extent that the Department, or its duly authorized representatives, exer-cises functions formerly vested in the U.S. Atomic Energy Commis-sion, its Chairman, members, offi-cers and components and transferred to the U.S. Energy Re-search and Development Admini-stration and to the Administrator thereof pursuant to sections 104 (b), (c) and (d) of the Energy Reor-ganization Act of 1974 (Pub. L. 93 - 438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95 - 91, 91 Stat. 565 at 577 - 578, 42 U.S.C. 7151). Effective dose equivalent means the sum of the products of the dose equivalent to the organ or tissue and the weighting factors applica-ble to each of the body organs or tissues that are irradiated. Weight-ing factors are: 0.25 for gonads, 0.15 for breast, 0.12 for red bone marrow, 0.12 for lungs, 0.03 for thyroid, 0.03 for bone surface, and 0.06 for each of the other five or-gans receiving the highest dose equivalent. Government agency means any executive department, commission, independent establishment, corpo-ration, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, divi-sion, service, office, officer, author-ity, administration, or other establishment in the executive branch of the Government; License, except where otherwise specified means a license for by-product material issued pursuant to the regulations in this part and parts 31 through 36 and 39 of this chapter; Medical use means the inten-tional internal or external admini-stration of byproduct material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user as defined in 10 CFR Part 35. Microcurie means that amount of radioactive material which disin-


tegrates at the rate of 37 thousand atoms per second; Millicurie means that amount of radioactive material which disinte-grates at the rate of 37 million at-oms per second; Person means: (1) Any individ-ual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Govern-ment agency other than the Com-mission or the Department, except that the Department shall be con-sidered a person within the mean-ing of the regulations in this part to the extent that its facilities and ac-tivities are subject to the licensing and related regulatory authority of the Commission pursuant to sec-tion 202 of the Energy Reorganiza-tion Act of 1974 (88 Stat. 1244), any State or any political subdivi-sion of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and (2) any legal successor, representative, agent, or agency of the foregoing; Physician means a medical doc-tor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; Podiatrist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry. Principal activities, as used in this part, means activities author-ized by the license which are essen-tial to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities inci-dental to decontamination or de-commissioning are not principal activities. Production facility means pro-duction facility as defined in the regulations contained in part 50 of this chapter; Research and development means: (1) Theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including

the experimental production and testing of models, devices, equip-ment, materials and processes. "Research and development" as used in this part and parts 31 through 35 does not include the internal or external administration of byproduct material, or the radia-tion therefrom, to human beings; Sealed source means any by product material that is encased in a capsule designed to prevent leak-age or escape of the byproduct ma-terial; Site area emergency means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response or-ganizations to protect persons off-site. Source material means source material as defined in the regula-tions contained in part 40 of this chapter; Special nuclear material means special nuclear material as defined in the regulations contained in part 70 of this chapter; United States, when used in a geographical sense, includes Puerto Rico and all territories and posses-sions of the United States; Utilization facility means a utili-zation facility as defined in the regulations contained in part 50 of this chapter; 1The Department facilities and activities identified in section 202 are: (1) Demonstration Liquid Metal Fast Breeder reactors when oper-ated as part of the power genera-tion facilities of an electric utility system, or when operated in any other manner for the purpose of demonstrating the suitability for commercial application of such a reactor. (2) Other demonstration nuclear reactors, except those in existence on January 19, 1975, when oper-ated as part of the power genera-tion facilities of an electric utility system, or when operated in any other manner for the purpose of demonstrating the suitability for commercial application of such a reactor. (3) Facilities used primarily for the receipt and storage of high-level radioactive wastes resulting from licensed activities.

(4) Retrievable Surface Storage Facilities and other facilities au-thorized for the express purpose of subsequent long-term storage of high-level radioactive waste gener-ated by the Department, which are not used for, or are part of, re-search and development activities. §30.5 Interpretations. Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part and parts 31 through 36 and 39 by any offi-cer or employee of the Commission other than a written interpretation by the General Counsel will be rec-ognized to be binding upon the Commission. [30 FR 8185, June 26, 1965, as amended at 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.6 Communications. (a) Unless otherwise specified or covered under the regional licens-ing program as provided in para-graph (b) of this section, any communication or report concern-ing the regulations in parts 30 through 36 and 39 of this chapter and any application filed under these regulations may be submitted to the Commission as follows: (1) By mail addressed to: Direc-tor, Office of Nuclear Material Safety and Safeguards, U.S. Nu-clear Regulatory Commission, Washington, DC 20555. (2) By delivery in person to the Commission's offices to the Direc-tor, Office of Nuclear Material Safety and Safeguards at: (i) 2120 L Street, NW., Washing-ton, DC; or (ii) 11545 Rockville Pike, Two White Flint North, Rockville, Mary-land. (b) The Commission has dele-gated to the five Regional Adminis-trators licensing authority for selected parts of its decentralized licensing program for nuclear mate-rials as described in paragraph (b)(1) of this section. Any communi-cation, report, or application cov-ered under this licensing program must be submitted as specified in paragraph (b)(2) of this section. (1) The delegated licensing pro-gram includes authority to issue, renew, amend, cancel, modify, sus-


pend, or revoke licenses for nuclear materials issued pursuant to 10 CFR parts 30 through 36, 39, 40, and 70 to all persons for academic, medical, and industrial uses, with the following exceptions: (i) Activities in the fuel cycle and special nuclear material in quanti-ties sufficient to constitute a critical mass in any room or area. This ex-ception does not apply to license modifications relating to termina-tion of special nuclear material li-censes that authorize possession of larger quantities when the case is referred for action from NRC's Headquarters to the Regional Ad-ministrators. (ii) Health and safety design re-view of sealed sources and devices and approval, for licensing pur-poses, of sealed sources and de-vices. (iii) Processing of source mate-rial for extracting of metallic com-pounds (including Zirconium, Hafnium, Tantalum, Titanium, Niobium, etc.). (iv) Distribution of products con-taining radioactive material to per-sons exempt pursuant 10 CFR 32.11 through 32.26. (v) New uses or techniques for use of byproducts, source, or spe-cial nuclear material. (2) Submissions -- (i) Region I. The regional licensing program in-volves all Federal facilities in the region and non-Federal licensees in the following Region I non-Agreement States and the District of Columbia: Connecticut, Dela-ware, Maine, Massachusetts, New Jersey, Pennsylvania, and Vermont. All inquiries, communications, and application for a new license or an amendment or renewal of an exist-ing license specified in paragraph (b)(1) of this section must be sent to: U.S. Nuclear Regulatory Com-mission, Region I, Nuclear Material Section B, 475 Allendale Road, King of Prussia, Pennsylvania 19406. (ii) Region II. The regional li-censing program involves all Fed-eral facilities in the region and non-Federal licensees in the following Region II non-Agreement States and territories: Virginia, West Vir-ginia, Puerto Rico, and the Virgin Islands. All inquiries, communica-tions, and applications for a new license or an amendment or re-

newal of an existing license speci-fied in paragraph (b)(1) of this section must be sent to U.S. Nu-clear Regulatory Commission, Re-gion II, Material Licensing/Inspection Branch, At-lanta Federal Center, 61 Forsyth Street, SW., Suite 23T85, Atlanta, Georgia, 30303. (iii) Region III. The regional li-censing program involves all Fed-eral facilities in the region and non-Federal licensees in the following Region III non-Agreement States: Indiana, Michigan, Minnesota, Mis-souri, Ohio, and Wisconsin. All in-quiries, communications, and applications for a new license or an amendment or renewal of an exist-ing license specified in paragraph (b)(1) of this section must be sent to: U.S. Nuclear Regulatory Com-mission, Region III, Material Licens-ing Section, 801 Warrenville Road, Lisle, Illinois 60532-4351. (iv) Region IV. The regional li-censing program involves all Fed-eral facilities in the region and non-Federal licensees in the following Region IV non-Agreement States and a territory: Alaska, Hawaii, Montana, Oklahoma, South Da-kota, Wyoming, and Guam. All in-quiries, communications, and applications for a new license or an amendment or renewal of an exist-ing license specified in paragraph (b)(1) of this section must be sent to: U.S. Nuclear Regulatory Com-mission, Region IV, Material Radia-tion Protection Section, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011. [48 FR 16031, Apr. 14, 1983, as amended at 49 FR 19630, May 9, 1984; 49 FR 47824, Dec. 7, 1984; 50 FR 14693, Apr. 11, 1985; 51 FR 36000, Oct. 8, 1986; 52 FR 8241, Mar. 17, 1987; 52 FR 38392, Oct. 16, 1987; 52 FR 48093, Dec. 18, 1987; 53 FR 3862, Feb. 10, 1988; 53 FR 43420, Oct. 27, 1988; 58 FR 7736, Feb. 9, 1993; 58 FR 64111, Dec. 6, 1993; 59 FR 17465, Apr. 13, 1994; 60 FR 24551, May 9, 1995; 62 FR 22880, Apr. 28, 1997] §30.7 Employee protection. (a) Discrimination by a Commis-sion licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain

protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reor-ganization Act of 1974, as amended, and in general are re-lated to the administration or en-forcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act. (1) The protected activities in-clude but are not limited to: (i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of this section or possible violations of require-ments imposed under either of those statutes; (ii) Refusing to engage in any practice made unlawful under ei-ther of the statutes named in para-graph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer; (iii) Requesting the Commission to institute action against his or her employer for the administration or enforcement of these require-ments; (iv) Testifying in any Commis-sion proceeding, or before Con-gress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text. (v) Assisting or participating in, or is about to assist or participate in, these activities. (2) These activities are protected even if no formal proceeding is ac-tually initiated as a result of the employee assistance or participa-tion. (3) This section has no applica-tion to any employee alleging dis-crimination prohibited by this section who, acting without direc-tion from his or her employer (or the employer's agent), deliberately causes a violation of any require-ment of the Energy Reorganization Act of 1974, as amended, or the Atomic Energy Act of 1954, as amended. (b) Any employee who believes that he or she has been discharged


or otherwise discriminated against by any person for engaging in pro-tected activities specified in para-graph (a)(1) of this section may seek a remedy for the discharge or dis-crimination through an administra-tive proceeding in the Department of Labor. The administrative pro-ceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Employment Standards Ad-ministration, Wage and Hour Divi-sion. The Department of Labor may order reinstatement, back pay, and compensatory damages. (c) A violation of paragraphs (a), (e), or (f) of this section by a Com-mission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant may be grounds for -- (1) Denial, revocation, or sus-pension of the license. (2) Imposition of a civil penalty on the licensee or applicant. (3) Other enforcement action. (d) Actions taken by an em-ployer, or others, which adversely affect an employee may be predi-cated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An em-ployee's engagement in protected activities does not automatically render him or her immune from discharge or discipline for legiti-mate reasons or from adverse ac-tion dictated by nonprohibited considerations. (e)(1) Each specific licensee, each applicant for a specific li-cense, and each general licensee subject to part 19 shall promi-nently post the revision of NRC Form 3, "Notice to Employees," ref-erenced in 10 CFR 19.11(c). (2) The posting of NRC Form 3 must be at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted not later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days follow-ing license termination.

(3) Copies of NRC Form 3 may be obtained by writing to the Re-gional Administrator of the appro-priate U.S. Nuclear Regulatory Commission Regional Office listed in Appendix D to Part 20 of this chapter or by calling the NRC In-formation and Records Manage-ment Branch at (301) 415 - 7230. (f) No agreement affecting the compensation, terms, conditions, or privileges of employment, includ-ing an agreement to settle a com-plaint filed by an employee with the Department of Labor pursuant to section 211 of the Energy Reorgani-zation Act of 1974, as amended, may contain any provision which would prohibit, restrict, or other-wise discourage an employee from participating in protected activity as defined in paragraph (a)(1) of this section including, but not lim-ited to, providing information to the NRC or to his or her employer on potential violations or other matters within NRC's regulatory responsi-bilities. [58 FR 52408, Oct. 8, 1993, as amended at 60 FR 24551, May 9, 1995; 61 FR 6764, Feb. 22, 1996] §30.8 Information collection re-quirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the in-formation collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Pa-perwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a col-lection of information unless it dis-plays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150 - 0017. (b) The approved information collection requirements contained in this part appear in §§ 30.9, 30.11, 30.15, 30.19, 30.20, 30.32, 30.34, 30.35, 30.36, 30.37, 30.38, 30.50, 30.51, 30.55, 30.56, and Appendices A, C, D, and E of this part. (c) This part contains informa-tion collection requirements in ad-dition to those approved under the control number specified in para-graph (a) of this section. These in-formation collection requirements

and the control numbers under which they are approved are as fol-lows: (1) In §§30.32, 30.37, and 30.38, NRC Form 313 is approved under control number 3150 - 0120. (2) In §30.36, NRC Form 314 is approved under control number 3150 - 0028. [49 FR 19625, May 9, 1984, as amended at 59 FR 61780, Dec. 2, 1994; 62 FR 52186, Oct. 6, 1997; 62 FR 63639, Dec. 2, 1997] Effective Date Note: At 62 FR 63639, Dec. 2, 1997, §30.8(b) was revised, effective Jan. 2, 1998. For the convenience of the user, the superseded text is set forth as fol-lows: §30.8 Information collection re-quirements: OMB approval. * * * * * (b) The approved information collection requirements contained in this part appear in §§ 30.9, 30.11, 30.15, 30.18, 30.19, 30.20, 30.32, 30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, and appendices A and C to this part. * * * * §30.9 Completeness and accu-racy of information. (a) Information provided to the Commission by an applicant for a license or by a licensee or informa-tion required by statute or by the Commission's regulations, orders, or license conditions to be main-tained by the applicant or the li-censee shall be complete and accurate in all material respects. (b) Each applicant or licensee shall notify the Commission of in-formation identified by the appli-cant or licensee as having for the regulated activity a significant im-plication for public health and safety or common defense and se-curity. An applicant or licensee vio-lates this paragraph only if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identi-fied as having a significant implica-tion for public health and safety or common defense and security. Noti-fication shall be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable


to information which is already re-quired to be provided to the Com-mission by other reporting or updating requirements. [52 FR 49371, Dec. 31, 1987] §30.10 Deliberate misconduct. (a) Any licensee, certificate of registration holder, applicant for a license or certificate of registration, employee of a licensee, certificate of registration holder or applicant; or any contractor (including a supplier or consultant), subcontractor, em-ployee of a contractor or subcon-tractor of any licensee or certificate of registration holder or applicant for a license or certificate of regis-tration, who knowingly provides to any licensee, applicant, certificate holder, contractor, or subcontrac-tor, any components, equipment, materials, or other goods or ser-vices that relate to a licensee's, cer-tificate holder's or applicant's activities in this part, may not: (1) Engage in deliberate miscon-duct that causes or would have caused, if not detected, a licensee, certificate of registration holder, or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or (2) Deliberately submit to the NRC, a licensee, certificate of regis-tration holder, an applicant, or a licensee's, certificate holder's or applicant's, contractor or subcon-tractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the NRC. (b) A person who violates para-graph (a)(1) or (a)(2) of this section may be subject to enforcement ac-tion in accordance with the proce-dures in 10 CFR part 2, subpart B. (c) For the purposes of para-graph (a)(1) of this section, deliber-ate misconduct by a person means an intentional act or omission that the person knows: (1) Would cause a licensee, cer-tificate of registration holder or ap-plicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commis-sion; or (2) Constitutes a violation of a requirement, procedure, instruc-tion, contract, purchase order, or

policy of a licensee, certificate of registration holder, applicant, con-tractor, or subcontractor. [56 FR 40689, Aug. 15, 1991]

Exemptions

§30.11 Specific exemptions. (a) The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the require-ments of the regulations in this part and parts 31 through 36 and 39 of this chapter as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. (b) Any licensee's activities are exempt from the requirements of this part to the extent that its ac-tivities are licensed under the re-quirements of part 72 of this chapter. (c) The Department of Energy is exempt from the requirements of this part to the extent that its ac-tivities are subject to the require-ments of part 60 or 63 of this chapter. (d) Except as specifically pro-vided in part 61 of this chapter, any licensee is exempt from the re-quirements of this part to the ex-tent that its activities are subject to the requirements of part 61 of this chapter. [37 FR 5746, Mar. 21, 1972, as amended at 39 FR 26279, July 18, 1974; 40 FR 8784, Mar. 3, 1975; 43 FR 6921, Feb. 21, 1978; 45 FR 65530, Oct. 3, 1980; 46 FR 13979, Feb. 25, 1981; 47 FR 57480, Dec. 27, 1982; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.12 Persons using byproduct material under certain Depart-ment of Energy and Nuclear Regulatory Commission con-tracts. Except to the extent that De-partment facilities or activities of the types subject to licensing pur-suant to section 202 of the Energy Reorganization Act of 1974 are in-volved, any prime contractor of the Department is exempt from the requirements for a license set forth in sections 81 and 82 of the Act and from the regulations in this part to the extent that such con-tractor, under his prime contract with the Department manufac-

tures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material for: (a) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of byproduct material to or from such site and the performance of con-tract services during temporary interruptions of such transporta-tion; (b) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or (c) The use or operation of nu-clear reactors or other nuclear de-vices in a United States Government-owned vehicle or ves-sel. In addition to the foregoing ex-emptions and subject to the re-quirement for licensing of Department facilities and activities pursuant to section 202 of the En-ergy Reorganization Act of 1974, any prime contractor or subcon-tractor of the Department or the Commission is exempt from the requirements for a license set forth in sections 81 and 82 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor manu-facturers, produces, transfers, re-ceives, acquires, owns, possesses, or uses byproduct material under his prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is au-thorized by law; and that, under the terms of the contract or sub-contract, there is adequate assur-ance that the work thereunder can be accomplished without undue risk to the public health and safety. [40 FR 8784, Mar. 3, 1975, as amended at 43 FR 6921, Feb. 17, 1978] §30.13 Carriers. Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are ex-empt from the regulations in this part and parts 31 through 36 and 39 of this chapter and the require-ments for a license set forth in sec-tion 81 of the Act to the extent that they transport or store byproduct material in the regular course of


carriage for another or storage inci-dent thereto. [37 FR 3985, Feb. 25, 1972, as amended at 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.14 Exempt concentrations. (a) Except as provided in para-graphs (c) and (d) of this section, any person is exempt from the re-quirements for a license set forth in section 81 of the Act and from the regulations in this part and parts 31 through 36 and 39 of this chap-ter to the extent that such person receives, possesses, uses, transfers, owns or acquires products or mate-rials containing byproduct material in concentrations not in excess of those listed in §30.70. (b) This section shall not be deemed to authorize the import of byproduct material or products containing byproduct material. (c) A manufacturer, processor, or producer of a product or mate-rial in an agreement State is ex-empt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part and parts 31, 32, 33, 34, 36 and 39 of this chapter to the extent that he transfers byproduct mate-rial contained in a product or mate-rial in concentrations not in excess of those specified in §30.70 and introduced into the product or ma-terial by a licensee holding a spe-cific license issued by an agreement State, the Commission, or the Atomic Energy Commission ex-pressly authorizing such introduc-tion. This exemption does not apply to the transfer of byproduct mate-rial contained in any food, bever-age, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or appli-cation to, a human being. (d) No person may introduce byproduct material into a product or material knowing or having rea-son to believe that it will be trans-ferred to persons exempt under this section or equivalent regulations of an Agreement State, except in ac-cordance with a license issued pur-suant to §32.11 of this chapter or the general license provided in §150.20 of this chapter. [30 FR 8185, June 26, 1965, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978;

52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.15 Certain items containing byproduct material. (a) Except for persons who apply byproduct material to, or persons who incorporate byproduct material into, the following products, or per-sons who initially transfer for sale or distribution the following prod-ucts containing byproduct material, any person is exempt from the re-quirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person re-ceives, possesses, uses, transfers, owns, or acquires the following products: (1) Timepieces or hands or dials containing not more than the fol-lowing specified quantities of by-product material and not exceeding the following specified levels of ra-diation: (i) 25 millicuries of tritium per timepiece, (ii) 5 millicuries of tritium per hand, (iii) 15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial), (iv) 100 microcuries of prome-thium 147 per watch or 200 micro-curies of promethium 147 per any other timepiece, (v) 20 microcuries of prome-thium 147 per watch hand or 40 microcuries of promethium 147 per other timepiece hand, (vi) 60 microcuries of prome-thium 147 per watch dial or 120 microcuries of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial), (vii) The levels of radiation from hands and dials containing prome-thium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber: (A) For wrist watches, 0.1 mil-lirad per hour at 10 centimeters from any surface, (B) For pocket watches, 0.1 mil-lirad per hour at 1 centimeter from any surface, (C) For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface. (2) Lock illuminators containing not more than 15 millicuries of trit-

ium or not more than 2 millicuries of promethium 147 installed in automobile locks. The levels of ra-diation from each lock illuminator containing promethium 147 will not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber. (3) Balances of precision con-taining not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part. (4) Automobile shift quadrants containing not more than 25 millicuries of tritium. (5) Marine compasses contain-ing not more than 750 millicuries of tritium gas and other marine navigational instruments contain-ing not more than 250 millicuries of tritium gas. (6) Thermostat dials and point-ers containing not more than 25 millicuries of tritium per thermo-stat. (7) [Reserved] (8) Electron tubes: Provided, That each tube does not contain more than one of the following specified quantities of byproduct material: (i) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube; (ii) 1 microcurie of cobalt-60; (iii) 5 microcuries of nickel-63; (iv) 30 microcuries of krypton-85; (v) 5 microcuries of cesium-137; (vi) 30 microcuries of prome-thium-147; And provided further, That the levels of radiation from each elec-tron tube containing byproduct material do not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber.(1) (9) Ionizing radiation measuring instruments containing, for pur-poses of internal calibration or standardization, one or more sources of byproduct material: Pro-vided, That; (i) Each source contains no more than one exempt quantity set forth in §30.71, Schedule B, and (ii) Each instrument contains no more than 10 exempt quantities. For purposes of this paragraph


(a)(9), an instrument's source(s) may contain either one type or dif-ferent types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quanti-ties in §30.71, Schedule B, pro-vided that the sum of such fractions shall not exceed unity. (iii) For purposes of this para-graph (a)(9), 0.05 microcurie of am-ericium-241 is considered an exempt quantity under §30.71, Schedule B. (10) Spark gap irradiators con-taining not more than 1 microcurie of cobalt-60 per spark gap irradia-tor for use in electrically ignited fuel oil burners having a firing rate of at least 3 gallons per hour (11.4 liters per hour). (b) Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in paragraph (a) of this section, or who desires to initially transfer for sale or distribution such products containing byproduct material, should apply for a specific license pursuant to §32.14 of this chapter, which license states that the prod-uct may be distributed by the li-censee to persons exempt from the regulations pursuant to paragraph (a) of this section. [31 FR 5316, Apr. 2, 1966, as amended at 31 FR 14349, Nov. 8, 1966; 32 FR 785, Jan. 24, 1967; 32 FR 6434, Apr. 26, 1967; 32 FR 13921, Oct. 6, 1967; 34 FR 6651, Apr. 18, 1969; 34 FR 19546, Dec. 11, 1969; 35 FR 6427, Apr. 22, 1970; 35 FR 8820, June 6, 1970; 43 FR 2387, Jan. 17, 1978; 43 FR 6921, Feb. 17, 1978; 46 FR 26471, May 13, 1981; 46 FR 46876, Sept. 23, 1981; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] 1For purposes of this paragraph "electron tubes" include spark gap tubes, power tubes, gas tubes in-cluding glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation de-tection tubes, and any other com-pletely sealed tube that is designed to conduct or control electrical cur-rents. §30.16 Resins containing scan-dium-46 and designed for sand-consolidation in oil wells.

Any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in Parts 20 and 30 through 36 and 39 of this chapter to the extent that such person re-ceives, possesses, uses, transfers, owns, or acquires synthetic plastic resins containing scandium-46 which are designed for sand-consolidation in oil wells, and which have been manufactured or initially transferred for sale or dis-tribution, in accordance with a spe-cific license issued pursuant to §32.17 of this chapter or equivalent regulations of an agreement State. The exemption in this section does not authorize the manufacture or initial transfer for sale or distribu-tion of any resins containing scan-dium-46. [32 FR 4241, Mar. 18, 1967, as amended at 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.18 Exempt quantities. (a) Except as provided in para-graphs (c) and (d) of this section, any person is exempt from the re-quirements for a license set forth in section 81 of the Act and from the regulations in parts 30 through 34, 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in in-dividual quantities each of which does not exceed the applicable quantity set forth in §30.71, Schedule B. (b) Any person who possesses byproduct material received or ac-quired prior to September 25, 1971 under the general license then pro-vided in §31.4 of this chapter is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 30 through 34 of this chapter to the extent that such person pos-sesses, uses, transfers, or owns such byproduct material. (c) This section does not author-ize for purposes of commercial dis-tribution the production, packaging, repackaging, or transfer of byproduct material or the incor-poration of byproduct material into products intended for commercial distribution. (d) No person may, for purposes of commercial distribution, transfer

byproduct material in the individ-ual quantities set forth in §30.71 Schedule B, knowing or having rea-son to believe that such quantities of byproduct material will be trans-ferred to persons exempt under this section or equivalent regulations of an Agreement State, except in ac-cordance with a license issued un-der §32.18 of this chapter, which license states that the byproduct material may be transferred by the licensee to persons exempt under this section or the equivalent regu-lations of an Agreement State. [35 FR 6427, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.19 Self-luminous products containing tritium, krypton-85, or promethium-147. (a) Except for persons who manufacture, process, produce, or initially transfer for sale or distri-bution self-luminous products con-taining tritium, krypton-85, or promethium-147, and except as provided in paragraph (c) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires trit-ium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, pro-duced, or initially transferred in accordance with a specific license issued pursuant to §32.22 of this chapter, which license authorizes the initial transfer of the product for use under this section. (b) Any person who desires to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or prome-thium-147, or to transfer such products for use pursuant to para-graph (a) of this section, should apply for a license pursuant to §32.22 of this chapter, which li-cense states that the product may be transferred by the licensee to persons exempt from the regula-tions pursuant to paragraph (a) of this section or equivalent regula-tions of an Agreement State.


(c) The exemption in paragraph (a) of this section does not apply to tritium, krypton-85, or prome-thium-147 used in products pri-marily for frivolous purposes or in toys or adornments. [34 FR 9026, June 6, 1969, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.20 Gas and aerosol detectors containing byproduct material. (a) Except for persons who manufacture, process, produce, or initially transfer for sale or distri-bution gas and aerosol detectors containing byproduct material, any person is exempt from the require-ments for a license set forth in sec-tion 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person re-ceives, possesses, uses, transfers, owns, or acquires byproduct mate-rial, in gas and aerosol detectors designed to protect life or property from fires and airborne hazards, and manufactured, processed, pro-duced, or initially transferred in accordance with a specific license issued pursuant to §32.26 of this chapter, which license authorizes the initial transfer of the product for use under this section. (b) Any person who desires to manufacture, process, or produce gas and aerosol detectors contain-ing byproduct material, or to ini-tially transfer such products for use pursuant to paragraph (a) of this section, should apply for a li-cense pursuant to §32.26 of this chapter, which license states that the product may be initially trans-ferred by the licensee to persons exempt from the regulations pur-suant to paragraph (a) of this sec-tion or equivalent regulations of an Agreement State. [34 FR 6653, Apr. 18, 1969, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.21 Radioactive drug: Cap-sules containing carbon-14 urea for "in vivo" diagnostic use for humans. (a) Except as provided in para-graphs (b) and (c) of this section,

any person is exempt from the re-quirements for a license set forth in Section 81 of the Act and from the regulations in this part and part 35 of this chapter provided that such person receives, possesses, uses, transfers, owns, or acquires cap-sules containing 37 kBq (1 Ci) car-bon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans. (b) Any person who desires to use the capsules for research in-volving human subjects shall apply for and receive a specific license pursuant to part 35 of this chapter. (c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to §32.21 of this chapter. (d) Nothing in this section re-lieves persons from complying with applicable FDA, other Federal, and State requirements governing re-ceipt, administration, and use of drugs. [62 FR 63640, Dec. 2, 1997] Effective Date Note: At 62 FR 63640, Dec. 2, 1997, §30.21 was added, effective Jan. 2, 1998.

Licenses

§30.31 Types of licenses. Licenses for byproduct material are of two types: General and spe-cific. (a) The Commission issues a specific license to a named person who has filed an application for the license under the provisions of this part and parts 32 through 36, and 39. (b) A general license is provided by regulation, grants authority to a person for certain activities involv-ing byproduct material, and is ef-fective without the filing of an application with the Commission or the issuance of a licensing docu-ment to a particular person. How-ever, registration with the Commission may be required by the particular general license. §30.32 Application for specific licenses. (a) A person may file an applica-tion in duplicate on NRC Form 313, "Application for Material License," in accordance with the instructions

in §30.6 of this chapter. Informa-tion contained in previous applica-tions, statements or reports filed with the Commission or the Atomic Energy Commission may be incor-porated by reference, provided that the reference is clear and specific. (b) The Commission may at any time after the filing of the original application, and before the expira-tion of the license, require further statements in order to enable the Commission to determine whether the application should be granted or denied or whether a license should be modified or revoked. (c) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf. (d) An application for license filed pursuant to the regulations in this part and parts 32 through 35 of this chapter will be considered also as an application for licenses authorizing other activities for which licenses are required by the Act, provided that the application specifies the additional activities for which licenses are requested and complies with regulations of the Commission as to applications for such licenses. (e) Each application for a by-product material license, other than a license exempted from part 170 of this chapter, shall be ac-companied by the fee prescribed in §170.31 of this chapter. No fee will be required to accompany an appli-cation for renewal or amendment of a license, except as provided in §170.31 of this chapter. (f) An application for a license to receive and possess byproduct ma-terial for the conduct of any activity which the Commission has deter-mined pursuant to subpart A of part 51 of this chapter will signifi-cantly affect the quality of the envi-ronment shall be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be con-ducted and shall be accompanied by any Environmental Report re-quired pursuant to subpart A of part 51 of this chapter. (g) An application for a specific license to use byproduct material in the form of a sealed source or in a device that contains the sealed source must either --


(1) Identify the source or device by manufacturer and model num-ber as registered with the Commis-sion under §32.210 of this chapter or with an Agreement State; or (2) Contain the information identified in §32.210(c). (h) As provided by §30.35, cer-tain applications for specific li-censes filed under this part and parts 32 through 35 of this chapter must contain a proposed decom-missioning funding plan or a certi-fication of financial assurance for decommissioning. In the case of renewal applications submitted before July 27, 1990, this submit-tal may follow the renewal applica-tion but must be submitted on or before July 27, 1990. (i)(1) Each application to pos-sess radioactive materials in un-sealed form, on foils or plated sources, or sealed in glass in excess of the quantities in §30.72, "Sched-ule C -- Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release," must contain either: (i) An evaluation showing that the maximum dose to a person off-site due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or (ii) An emergency plan for re-sponding to a release of radioactive material. (2) One or more of the following factors may be used to support an evaluation submitted under para-graph (i)(1)(i) of this section: (i) The radioactive material is physically separated so that only a portion could be involved in an ac-cident; (ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged; (iii) The release fraction in the respirable size range would be lower than the release fraction shown §30.72 due to the chemical or physical form of the material; (iv) The solubility of the radioac-tive material would reduce the dose received; (v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in §30.72;

(vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in §30.72; or (vii) Other factors appropriate for the specific facility. (3) An emergency plan for re-sponding to a release of radioactive material submitted under para-graph (i)(1)(ii) of this section must include the following information: (i) Facility description. A brief description of the licensee's facility and area near the site. (ii) Types of accidents. An identi-fication of each type of radio-active materials accident for which pro-tective actions may be needed. (iii) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies. (iv) Detection of accidents. Iden-tification of the means of detecting each type of accident in a timely manner. (v) Mitigation of consequences. A brief description of the means and equipment for mitigating the con-sequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment. (vi) Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials. (vii) Responsibilities. A brief de-scription of the responsibilities of licensee personnel should an acci-dent occur, including identification of personnel responsible for promptly notifying offsite response organizations and the NRC; also responsibilities for developing, maintaining, and updating the plan. (viii) Notification and coordina-tion. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assis-tance for the treatment of contami-nated injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some person-nel, parts of the facility, and some equipment will not prevent the noti-fication and coordination. The li-censee shall also commit to notify

the NRC operations center immedi-ately after notification of the appro-priate offsite response organizations and not later than one hour after the licensee declares an emergency.(1) (x) Training. A brief description of the frequency, performance ob-jectives and plans for the training that the licensee will provide work-ers on how to respond to an emer-gency including any special instructions and orientation tours the licensee would offer to fire, po-lice, medical and other emergency personnel. The training shall famil-iarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibili-ties in the event of accident scenar-ios postulated as most probable for the specific site, including the use of team training for such scenarios. (xi) Safe shutdown. A brief de-scription of the means of restoring the facility to a safe condition after an accident. (xii) Exercises. Provisions for conducting quarterly communica-tions checks with offsite response organizations and biennial onsite exercises to test response to simu-lated emergencies. Quarterly com-munications checks with offsite response organizations must in-clude the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises although recom-mended is not required. Exercises must use accident scenarios postu-lated as most probable for the spe-cific site and the scenarios shall not be known to most exercise partici-pants. The licensee shall critique each exercise using individuals not having direct implementation re-sponsibility for the plan. Critiques of exercises must evaluate the ap-propriateness of the plan, emer-gency procedures, facilities, equipment, training of personnel, and overall effectiveness of the re-sponse. Deficiencies found by the critiques must be corrected. (xiii) Hazardous chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Commu-nity Right-to-Know Act of 1986,


title III, Pub. L. 99 - 499, if applica-ble to the applicant's activities at the proposed place of use of the byproduct material. (4) The licensee shall allow the offsite response organizations ex-pected to respond in case of an ac-cident 60 days to comment on the licensee's emergency plan before submitting it to NRC. The licensee shall provide any comments re-ceived within the 60 days to the NRC with the emergency plan. (ix) Information to be communi-cated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite re-sponse organizations and to the NRC. [30 FR 8185, June 26, 1965, as amended at 36 FR 145, Jan. 6, 1971; 37 FR 5747, Mar. 21, 1972; 43 FR 6922, Feb. 17, 1978; 49 FR 9403, Mar. 12, 1984; 49 FR 27924, July 9, 1984; 52 FR 27786, July 24, 1987; 53 FR 24044, June 27, 1988; 54 FR 14060, Apr. 7, 1989] 1These reporting requirements do not superceed or release licen-sees of complying with the re-quirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99 - 499 or other state or federal reporting requirements. §30.33 General requirements for issuance of specific licenses. (a) An application for a specific license will be approved if: (1) The application is for a pur-pose authorized by the Act; (2) The applicant's proposed equipment and facilities are ade-quate to protect health and mini-mize danger to life or property; (3) The applicant is qualified by training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property; (4) The applicant satisfies any special requirements contained in parts 32 through 36 and 39; and (5) In the case of an application for a license to receive and possess byproduct material for the conduct of any activity which the Commis-sion determines will significantly affect the quality of the environ-ment, the Director of Nuclear Mate-

rial Safety and Safeguards or his designee, before commencement of construction of the plant or facility in which the activity will be con-ducted, on the basis of information filed and evaluations made pursu-ant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, eco-nomic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the is-suance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess byproduct ma-terial in such plant or facility. As used in this paragraph the term "commencement of construction" means any clearing of land, excava-tion, or other substantial action that would adversely affect the en-vironment of a site. The term does not mean site exploration, neces-sary roads for site exploration, bor-ings to determine foundation conditions, or other preconstruc-tion monitoring or testing to estab-lish background information related to the suitability of the site or the protection of environmental values. (b) Upon a determination that an application meets the require-ments of the Act, and the regula-tions of the Commission, the Commission will issue a specific license authorizing the possession and use of byproduct material (Form NRC 374, "Byproduct Mate-rial License"). [30 FR 8185, June 26, 1965, as amended at 36 FR 12731, July 7, 1971; 37 FR 5747. Mar. 21, 1972; 39 FR 26279, July 18, 1974; 43 FR 6922, Feb. 17, 1978; 49 FR 9403, Mar. 12, 1984; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.34 Terms and conditions of licenses. (a) Each license issued pursuant to the regulations in this part and the regulations in parts 31 through 36 and 39 of this chapter shall be subject to all the provisions of the Act, now or hereafter in effect, and to all valid rules, regulations and orders of the Commission.

(b) No license issued or granted pursuant to the regulations in this part and parts 31 through 36, and 39 nor any right under a license shall be transferred, assigned or in any manner disposed of, either vol-untarily or involuntarily, directly or indirectly, through transfer of con-trol of any license to any person, unless the Commission shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing. (c) Each person licensed by the Commission pursuant to the regu-lations in this part and parts 31 through 36 and 39 shall confine his possession and use of the byprod-uct material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the regulations in this part and parts 31 through 36 and 39 of this chapter shall carry with it the right to receive, acquire, own, and pos-sess byproduct material. Prepara-tion for shipment and transport of byproduct material shall be in ac-cordance with the provisions of part 71 of this chapter. (d) Each license issued pursu-ant to the regulations in this part and parts 31 through 36 and 39 shall be deemed to contain the pro-visions set forth in section 183b. - d., inclusive, of the Act, whether or not these provisions are expressly set forth in the license. (e) The Commission may incor-porate, in any license issued pur-suant to the regulations in this part and parts 31 through 36 and 39, at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional require-ments and conditions with respect to the licensee's receipt, posses-sion, use and transfer of byproduct material as it deems appropriate or necessary in order to: (1) Promote the common defense and security; (2) Protect health or to minimize danger to life or property; (3) Protect restricted data; (4) Require such reports and the keeping of such records, and to provide for such inspections of ac-tivities under the license as may be necessary or appropriate to effectu-ate the purposes of the Act and regulations thereunder.


(f) Licensees required to submit emergency plans by §30.32(i) shall follow the emergency plan approved by the Commission. The licensee may change the approved without Commission approval only if the changes do not decrease the effec-tiveness of the plan. The licensee shall furnish the change to the ap-propriate NRC Regional Office specified in §30.6 and to affected offsite response organizations within six months after the change is made. Proposed changes that decrease, or potentially decrease, the effectiveness of the approved emergency plan may not be imple-mented without prior application to and prior approval by the Commis-sion. (g) Each licensee preparing technetium-99m radiopharmaceu-ticals from molybdenum-99/technetium-99m generators shall test the generator eluates for molybdenum-99 breakthrough in accordance with §35.204 of this chapter. The licensee shall record the results of each test and retain each record for three years after the record is made. (h)(1) Each general licensee that is required to register by Sec. 31.5(c)(13) of this chapter and each specific licensee shall notify the appropriate NRC Regional Adminis-trator, in writing, immediately fol-lowing the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against: (i) The licensee; (ii) An entity (as that term is defined in 11 U.S.C. 101(14)) con-trolling the licensee or listing the license or licensee as property of the estate; or (iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee. (2) This notification must indi-cate: (i) The bankruptcy court in which the petition for bankruptcy was filed; and (ii) The date of the filing of the petition. §30.35 Financial assurance and recordkeeping for decommission-ing. (a) Each applicant for a specific license authorizing the possession

and use of unsealed byproduct ma-terial of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in appendix B to part 30 shall submit a decommissioning funding plan as described in para-graph (e) of this section. The de-commissioning funding plan must also be submitted when a combina-tion of isotopes is involved if R di-vided by 105 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quan-tity of each isotope to the applicable value in appendix B to part 30. (b) Each applicant for a specific license authorizing possession and use of byproduct material of half-life greater than 120 days and in quantities specified in paragraph (d) of this section shall either -- (1) Submit a decommissioning funding plan as described in para-graph (e) of this section; or (2) Submit a certification that financial assurance for decommis-sioning has been provided in the amount prescribed by paragraph (d) of this section using one of the methods described in paragraph (f) of this section. For an applicant, this certification may state that the appropriate assurance will be ob-tained after the application has been approved and the license is-sued but before the receipt of li-censed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument ob-tained to satisfy the requirements of paragraph (f) of this section must be submitted to NRC before receipt of licensed material. If the applicant does not defer execution of the fi-nancial instrument, the applicant shall submit to NRC, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of para-graph (f) of this section. (c)(1) Each holder of a specific license issued on or after July 27, 1990, which is of a type described in paragraph (a) or (b) of this sec-tion, shall provide financial assur-ance for decommissioning in accordance with the criteria set forth in this section. (2) Each holder of a specific li-cense issued before July 27, 1990, and of a type described in para-

graph (a) of this section shall sub-mit, on or before July 27, 1990, a decommissioning funding plan as described in paragraph (e) of this section or a certification of financial assurance for decommissioning in an amount at least equal to $750,000 in accordance with the criteria set forth in this section. If the licensee submits the certifica-tion of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in any application for license renewal. (3) Each holder of a specific li-cense issued before July 27, 1990, and of a type described in para-graph (b) of this section shall sub-mit, on or before July 27, 1990, a decommissioning funding plan as described, in paragraph (e) of this section, or a certification of finan-cial assurance for decommissioning in accordance with the criteria set forth in this section. (4) Any licensee who has sub-mitted an application before July 27, 1990, for renewal of license in accordance with §30.37 shall pro-vide financial assurance for de-commissioning in accordance with paragraphs (a) and (b) of this sec-tion. This assurance must be sub-mitted when this rule becomes effective November 24, 1995. (d) Table of required amounts of financial assurance for decommis-sioning by quantity of material. greater than 104 but less than or equal to 105 times the applicable quantities of appendix B to part 30 in unsealed form. (For a combina-tion of isotopes, if R, as defined in §30.35(a), divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1.) .... $750,000 greater than 103 but less than or equal to 104 times the applicable quantities of appendix B to part 30 in unsealed form. (For a combina-tion of isotopes, if R, as defined in §30.35(a), divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1.) .... $150,000 greater than 1010 times the ap-plicable quantities of appendix B to part 30 in sealed sources or plated foils. (For a combination of iso-topes, if R, as defined in §30.35(a), divided by 1010 is greater than 1). .... $75,000 (e) Each decommissioning fund-ing plan must contain a cost esti-


mate for decommissioning and a description of the method of assur-ing funds for decommissioning from paragraph (f) of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility. The decommissioning funding plan must also contain a certification by the licensee that financial assurance for decommis-sioning has been provided in the amount of the cost estimate for de-commissioning and a signed origi-nal of the financial instrument obtained to satisfy the require-ments of paragraph (f) of this sec-tion. (f) Financial assurance for de-commissioning must be provided by one or more of the following methods: (1) Prepayment. Prepayment is the deposit prior to the start of op-eration into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be suf-ficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of de-posit, or deposit of government se-curities. (2) A surety method, insurance, or other guarantee method. These methods guarantee that decommis-sioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guar-antee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix A to this part. A parent company guar-antee may not be used in combina-tion with other financial methods to satisfy the requirements of this sec-tion. For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as con-tained in appendix C to this part. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in appendix D to this part. For nonprofit entities, such as

colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in appendix E to this part. A guarantee by the applicant or licensee may not be used in combination with any other finan-cial methods used to satisfy the requirements of this section or in any situation where the applicant or licensee has a parent company holding majority control of the vot-ing stock of the company. Any surety method or insurance used to provide financial assurance for de-commissioning must contain the following conditions: (i) The surety method or insur-ance must be open-ended or, if written for a specified term, such as five years, must be renewed auto-matically unless 90 days or more prior to the renewal date, the issuer notifies the Commission, the bene-ficiary, and the licensee of its inten-tion not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automati-cally prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement ac-ceptable to the Commission within 30 days after receipt of notification of cancellation. (ii) The surety method or insur-ance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Commission. An acceptable trustee includes an appropriate State or Federal gov-ernment agency or an entity which has the authority to act as a trus-tee and whose trust operations are regulated and examined by a Fed-eral or State agency. (iii) The surety method or insur-ance must remain in effect until the Commission has terminated the license. (3) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from li-censee assets and outside the li-censee's administrative control in

which the total amount of funds would be sufficient to pay decom-missioning costs at the time termi-nation of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of de-posit, or deposit of government se-curities. The surety or insurance provisions must be as stated in paragraph (f)(2) of this section. (4) In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the Table in paragraph (d) of this section, and indicating that funds for decom-missioning will be obtained when necessary. (5) When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such gov-ernmental entity. (g) Each person licensed under this part or parts 32 through 36 and 39 of this chapter shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are trans-ferred or assigned in accordance with §30.34(b), licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, refer-ence to these records and their lo-cations may be used. Information the Commission considers impor-tant to decommissioning consists of -- (1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup proce-dures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as con-crete. These records must include any known information on identifi-cation of involved nuclides, quanti-ties, forms, and concentrations.


(2) As-built drawings and modi-fications of structures and equip-ment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If re-quired drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations. (3) Except for areas containing only sealed sources (provided the sources have not leaked or no con-tamination remains after any leak) or byproduct materials having only half-lives of less than 65 days, a list contained in a single document and updated every 2 years, of the fol-lowing: (i) All areas designated and for-merly designated restricted areas as defined in 10 CFR 20.1003 (For requirements prior to January 1, 1994, see 10 CFR 20.3 as con-tained in the CFR edition revised as of January 1, 1993.); (ii) All areas outside of restricted areas that require documentation under §30.35(g)(1). (iii) All areas outside of re-stricted areas where current and previous wastes have been buried as documented under 10 CFR 20.2108; and (iv) All areas outside of re-stricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 10 CFR part 20, subpart E, or apply for approval for disposal under 10 CFR 20.2002. (4) Records of the cost estimate performed for the decommissioning funding plan or of the amount cer-tified for decommissioning, and records of the funding method used for assuring funds if either a fund-ing plan or certification is used. [53 FR 24044, June 27, 1988, as amended at 56 FR 23471, May 21, 1991; 58 FR 39633, July 26, 1993; 58 FR 67659, Dec. 22, 1993; 58 FR 68730, Dec. 29, 1993; 59 FR 1618, Jan. 12, 1994; 60 FR 38238, July 26, 1995; 61 FR 24673, May 16, 1996; 62 FR 39090, July 21, 1997]

§30.36 Expiration and termina-tion of licenses and decommis-sioning of sites and separate buildings or outdoor areas. (a)(1) Except as provided in paragraph (a)(2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under §30.37 not less than 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph). If an appli-cation for renewal has been filed at least 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph), the exist-ing license expires at the end of the day on which the Commission makes a final determination to deny the renewal application or, if the determination states an expira-tion date, the expiration date stated in the determination. (2) Each specific license that has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deemed to have an expiration date that is five years after the expiration date stated in the current license. (3) The following specific li-censes are not subject to, or other-wise affected by, the provisions of paragraph (a)(2) of this section: (i) Specific licenses for which, on February 15, 1996, an evaluation or an emergency plan is required in accordance with §30.32(i); (ii) Specific licenses whose hold-ers are subject to the financial as-surance requirements specified in 10 CFR 30.35, and on February 15, 1996, the holders either: (A) Have not submitted a de-commissioning funding plan or cer-tification of financial assurance for decommissioning; or (B) Have not received written notice that the decommissioning funding plan or certification of fi-nancial assurance for decommis-sioning is acceptable; (iii) Specific licenses whose holders are listed in the SDMP List

published in NUREG 1444, Sup-plement 1 (November 1995); (iv) Specific licenses whose issu-ance, amendment, or renewal, as of February 15, 1996, is not a cate-gorical exclusion under 10 CFR 51.22(c)(14) and, therefore, need an environmental assessment or envi-ronmental impact statement pur-suant to Subpart A of Part 51 of this chapter; (v) Specific licenses whose hold-ers have not had at least one NRC inspection of licensed activities be-fore February 15, 1996; (vi) Specific licenses whose hold-ers, as the result of the most recent NRC inspection of licensed activities conducted before Febru-ary 15, 1996, have been: (A) Cited for a Severity Level I, II, or III violation in a Notice of Viola-tion; (B) Subject to an Order issued by the NRC; or (C) Subject to a Confirmatory Action Letter issued by the NRC. (vii) Specific licenses with expi-ration dates before July 1, 1995, for which the holders have submit-ted applications for renewal under 10 CFR 30.37 of this part. (b) Each specific license revoked by the Commission expires at the end of the day on the date of the Commission's final determination to revoke the license, or on the ex-piration date stated in the determi-nation, or as otherwise provided by Commission Order. (c) Each specific license contin-ues in effect, beyond the expiration date if necessary, with respect to possession of byproduct material until the Commission notifies the licensee in writing that the license is terminated. During this time, the licensee shall -- (1) Limit actions involving by-product material to those related to decommissioning; and (2) Continue to control entry to restricted areas until they are suit-able for release in accordance with NRC requirements. (d) Within 60 days of the occur-rence of any of the following, con-sistent with the administrative directions in §30.6, each licensee shall provide notification to the NRC in writing of such occurrence, and either begin decommissioning its site, or any separate building or outdoor area that contains residual


radioactivity so that the building or outdoor area is suitable for release in accordance with NRC require-ments, or submit within 12 months of notification a decommissioning plan, if required by paragraph (g)(1) of this section, and begin decom-missioning upon approval of that plan if -- (1) The license has expired pur-suant to paragraph (a) or (b) of this section; or (2) The licensee has decided to permanently cease principal activi-ties, as defined in this part, at the entire site or in any separate build-ing or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuit-able for release in accordance with NRC requirements; or (3) No principal activities under the license have been conducted for a period of 24 months; or (4) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with NRC requirements. (e) Coincident with the notifica-tion required by paragraph (d) of this section, the licensee shall maintain in effect all decommis-sioning financial assurances estab-lished by the licensee pursuant to §30.35 in conjunction with a li-cense issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be de-creased, as appropriate, to cover the detailed cost estimate for de-commissioning established pursu-ant to paragraph (g)(4)(v) of this section. (1) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommission-ing plan shall do so when this rule becomes effective November 24, 1995. (2) Following approval of the decommissioning plan, a licensee may reduce the amount of the fi-nancial assurance as decommis-sioning proceeds and radiological contamination is reduced at the site with the approval of the Com-mission.

(f) The Commission may grant a request to extend the time periods established in paragraph (d) if the Commission determines that this relief is not detrimental to the pub-lic health and safety and is other-wise in the public interest. The request must be submitted no later than 30 days before notification pursuant to paragraph (d) of this section. The schedule for decom-missioning set forth in paragraph (d) of this section may not com-mence until the Commission has made a determination on the re-quest. (g)(1) A decommissioning plan must be submitted if required by license condition or if the proce-dures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously ap-proved by the Commission and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases: (i) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; (ii) Workers would be entering areas not normally occupied where surface contamination and radia-tion levels are significantly higher than routinely encountered during operation; (iii) Procedures could result in significantly greater airborne con-centrations of radioactive materials than are present during operation; or (iv) Procedures could result in significantly greater releases of ra-dioactive material to the environ-ment than those associated with operation. (2) The Commission may ap-prove an alternate schedule for submittal of a decommissioning plan required pursuant to para-graph (d) of this section if the Commission determines that the alternative schedule is necessary to the effective conduct of decommis-sioning operations and presents no undue risk from radiation to the public health and safety and is oth-erwise in the public interest. (3) Procedures such as those listed in paragraph (g)(1) of this section with potential health and safety impacts may not be carried

out prior to approval of the decom-missioning plan. (4) The proposed decommission-ing plan for the site or separate building or outdoor area must in-clude: (i) A description of the condi-tions of the site or separate build-ing or outdoor area sufficient to evaluate the acceptability of the plan; (ii) A description of planned de-commissioning activities; (iii) A description of methods used to ensure protection of work-ers and the environment against radiation hazards during decom-missioning; (iv) A description of the planned final radiation survey; and (v) An updated detailed cost es-timate for decommissioning, com-parison of that estimate with present funds set aside for decom-missioning, and a plan for assuring the availability of adequate funds for completion of decommissioning. (vi) For decommissioning plans calling for completion of decommis-sioning later than 24 months after plan approval, the plan shall in-clude a justification for the delay based on the criteria in paragraph (i) of this section. (5) The proposed decommission-ing plan will be approved by the Commission if the information therein demonstrates that the de-commissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately pro-tected. (h)(1) Except as provided in paragraph (i) of this section, licen-sees shall complete decommission-ing of the site or separate building or outdoor area as soon as practi-cable but no later than 24 months following the initiation of decom-missioning. (2) Except as provided in para-graph (i) of this section, when de-commissioning involves the entire site, the licensee shall request li-cense termination as soon as prac-ticable but no later than 24 months following the initiation of decom-missioning. (i) The Commission may approve a request for an alternative sched-ule for completion of decommis-sioning of the site or separate building or outdoor area,


and license termination if appropri-ate, if the Commission determines that the alternative is warranted by consideration of the following: (1) Whether it is technically fea-sible to complete decommissioning within the allotted 24-month pe-riod; (2) Whether sufficient waste dis-posal capacity is available to allow completion of decommissioning within the allotted 24-month pe-riod; (3) Whether a significant volume reduction in wastes requiring dis-posal will be achieved by allowing short-lived radionuclides to decay; (4) Whether a significant reduc-tion in radiation exposure to work-ers can be achieved by allowing short-lived radionuclides to decay; and (5) Other site-specific factors which the Commission may con-sider appropriate on a case-by-case basis, such as the regulatory re-quirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee. (j) As the final step in decom-missioning, the licensee shall -- (1) Certify the disposition of all licensed material, including accu-mulated wastes, by submitting a completed NRC Form 314 or equivalent information; and (2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other man-ner that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E. The licen-see shall, as appropriate-- (i) Report levels of gamma radia-tion in units of millisieverts (micro-roentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or mi-crocuries) per 100 square centime-ters -- removable and fixed -- for surfaces, megabecquerels (micro-curies) per milliliter for water, and becquerels (picocuries) per gram for

solids such as soils or concrete; and (ii) Specify the survey instru-ment(s) used and certify that each instrument is properly calibrated and tested. (k) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Commission determines that: (1) Byproduct material has been properly disposed; (2) Reasonable effort has been made to eliminate residual radioac-tive contamination, if present; and (3)(i) A radiation survey has been performed which demon-strates that the premises are suit-able for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E; or (ii) Other information submitted by the licensee is sufficient to dem-onstrate that the premises are suit-able for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E. (4) Records required by §30.51 (d) and (f) have been received. [59 FR 36034, July 15, 1994, as amended at 60 FR 38238, July 26, 1995; 61 FR 1114, Jan. 16, 1996; 61 FR 24673, May 16, 1996; 61 FR 29637, June 12, 1996; 62 FR 39090, July 21, 1997] §30.37 Application for renewal of licenses. (a) Application for renewal of a specific license must be filed on NRC Form 313 and in accordance with §30.32. (b) If any licensee granted the extension described in 10 CFR 30.36(a)(2) has a currently pending renewal application for the ex-tended license, that application will be considered withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded. [59 FR 36035, July 15, 1994, as amended at 61 FR 1114, Jan. 16, 1996] §30.38 Application for amend-ment of licenses. Applications for amendment of a license shall be filed on Form NRC - 313 in accordance with §30.32 and shall specify the respects in which the licensee desires its license to be

amended and the grounds for the amendment. [49 FR 19625, May 9, 1984] §30.39 Commission action on applications to renew or amend. In considering an application by a licensee to renew or amend his license the Commission will apply the applicable criteria set forth in §30.33 and parts 32 through 36 and 39 of this chapter. [30 FR 8185, June 26, 1965, as amended at 43 FR 6922, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993] §30.41 Transfer of byproduct material. (a) No licensee shall transfer byproduct material except as au-thorized pursuant to this section. (b) Except as otherwise provided in his license and subject to the provisions of paragraphs (c) and (d) of this section, any licensee may transfer byproduct material: (1) To the Department; (2) To the agency in any Agree-ment State which regulates radio-active material pursuant to an agreement under section 274 of the Act; (3) To any person exempt from the licensing requirements of the Act and regulations in this part, to the extent permitted under such exemption; (4) To any person in an Agree-ment State, subject to the jurisdic-tion of that State, who has been exempted from the licensing re-quirements and regulations of that State, to the extent permitted under such exemption; (5) To any person authorized to receive such byproduct material under terms of a specific license or a general license or their equiva-lents issued by the Atomic Energy Commission, the Commission, or an Agreement State; (6) To a person abroad pursuant to an export license issued under part 110 of this chapter; or (7) As otherwise authorized by the Commission in writing. (c) Before transferring byproduct material to a specific licensee of the Commission or an Agreement State or to a general licensee who is re-quired to register with the Commis-sion or with an Agreement State prior to receipt of the byproduct


material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quan-tity of byproduct material to be transferred. (d) The following methods for the verification required by para-graph (c) of this section are accept-able: (1) The transferor may have in his possession, and read, a current copy of the transferee's specific li-cense or registration certificate; (2) The transferor may have in his possession a written certifica-tion by the transferee that he is authorized by license or registra-tion certificate to receive the type, form, and quantity of byproduct material to be transferred, specify-ing the license or registration cer-tificate number, issuing agency and expiration date; (3) For emergency shipments the transferor may accept oral cer-tification by the transferee that he is authorized by license or registra-tion certificate to receive the type, form, and quantity of byproduct material to be transferred, specify-ing the license or registration cer-tificate number, issuing agency and expiration date: Provided, That the oral certification is confirmed in writing within 10 days; (4) The transferor may obtain other sources of information com-piled by a reporting service from official records of the Commission or the licensing agency of an Agreement State as to the identity of licensees and the scope and ex-piration dates of licenses and regis-tration; or (5) When none of the methods of verification described in paragraphs (d)(1) to (4) of this section are read-ily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirma-tion from the Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the byproduct material. [38 FR 33969, Dec. 10, 1973, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6922, Feb. 17, 1978]

Records, Inspections, Tests, and Reports

§30.50 Reporting requirements.

(a) Immediate report. Each licen-see shall notify the NRC as soon as possible but not later than 4 hours after the discovery of an event that prevents immediate protective ac-tions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explo-sions, toxic gas releases, etc.). (b) Twenty-four hour report. Each licensee shall notify the NRC within 24 hours after the discovery of any of the following events in-volving licensed material: (1) An unplanned contamination event that: (i) Requires access to the con-taminated area, by workers or the public, to be restricted for more than 24 hours by imposing addi-tional radiological controls or by prohibiting entry into the area; (ii) Involves a quantity of mate-rial greater than five times the low-est annual limit on intake specified in appendix B of §§20.1001 - 20.2401 of 10 CFR part 20 for the material; and (iii) Has access to the area re-stricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination. (2) An event in which equipment is disabled or fails to function as designed when: (i) The equipment is required by regulation or license condition to prevent releases exceeding regula-tory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; (ii) The equipment is required to be available and operable when it is disabled or fails to function; and (iii) No redundant equipment is available and operable to perform the required safety function. (3) An event that requires un-planned medical treatment at a medical facility of an individual with spreadable radioactive con-tamination on the individual's clothing or body. (4) An unplanned fire or explo-sion damaging any licensed mate-rial or any device, container, or equipment containing licensed ma-terial when:

(i) The quantity of material in-volved is greater than five times the lowest annual limit on intake speci-fied in appendix B of §§20.1001 - 20.2401 of 10 CFR part 20 for the material; and (ii) The damage affects the integ-rity of the licensed material or its container. (c) Preparation and submission of reports. Reports made by licen-sees in response to the require-ments of this section must be made as follows: (1) Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operations Center.(1) To the extent that the information is avail-able at the time of notification, the information provided in these re-ports must include: (i) The caller's name and call back telephone number; (ii) A description of the event, including date and time; (iii) The exact location of the event; (iv) The isotopes, quantities, and chemical and physical form of the licensed material involved; and (v) Any personnel radiation ex-posure data available. (2) Written report. Each licensee who makes a report required by paragraph (a) or (b) of this section shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this require-ment if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be sent to the U.S. Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555, with a copy to the appropriate NRC Re-gional office listed in appendix D of 10 CFR part 20. The reports must include the following: (i) A description of the event, including the probable cause and the manufacturer and model num-ber (if applicable) of any equipment that failed or malfunctioned; (ii) The exact location of the event; (iii) The isotopes, quantities, and chemical and physical form of the licensed material involved; (iv) Date and time of the event;


(v) Corrective actions taken or planned and the results of any evaluations or assessments; and (vi) The extent of exposure of individuals to radiation or to radio-active materials without identifica-tion of individuals by name. (3) The provisions of §30.50 do not apply to licensees subject to the notification requirements in §50.72. They do apply to those part 50 li-censees possessing material li-censed under part 30, who are not subject to the notification require-ments in §50.72. [56 FR 40767, Aug. 16, 1991, as amended at 59 FR 14086, Mar. 25, 1994] 1The commercial telephone number for the NRC Operations Center is (301) 816 - 5100. §30.51 Records. (a) Each person who receives byproduct material pursuant to a license issued pursuant to the regulations in this part and parts 31 through 36 of this chapter shall keep records showing the receipt, transfer, and disposal of the by-product material as follows: (1) The licensee shall retain each record of receipt of byproduct mate-rial as long as the material is pos-sessed and for three years following transfer or disposal of the material. (2) The licensee who transferred the material shall retain each re-cord of transfer for three years after each transfer unless a specific re-quirement in another part of the regulations in this chapter dictates otherwise. (3) The licensee who disposed of the material shall retain each re-cord of disposal of byproduct mate-rial until the Commission terminates each license that au-thorizes disposal of the material. (b) The licensee shall retain each record that is required by the regu-lations in this part and parts 31 through 36 of this chapter or by license condition for the period specified by the appropriate regula-tion or license condition. If a reten-tion period is not otherwise specified by regulation or license condition, the record must be re-tained until the Commission termi-nates each license that authorizes the activity that is subject to the recordkeeping requirement.

(c)(1) Records which must be maintained pursuant to this part and parts 31 through 36 of this chapter may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention pe-riod. Records such as letters, draw-ings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain ade-quate safeguards against tampering with and loss of records. (2) If there is a conflict between the Commission's regulations in this part and parts 31 through 36 and 39 of this chapter, license con-dition, or other written Commission approval or authorization pertain-ing to the retention period for the same type of record, the retention period specified in the regulations in this part and parts 31 through 36 and 39 of this chapter for such records shall apply unless the Commission, pursuant to §30.11, has granted a specific exemption from the record retention require-ments specified in the regulations in this part or parts 31 through 36 and 39 of this chapter. (d) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an un-sealed form, shall forward the fol-lowing records to the appropriate NRC Regional Office: (1) Records of disposal of li-censed material made under §§20.2002 (including burials au-thorized before January 28, 1981(1)), 20.2003, 20.2004, 20.2005; and (2) Records required by §20.2103(b)(4). (e) If licensed activities are transferred or assigned in accor-dance with §30.34(b), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for

maintaining these records until the license is terminated: (1) Records of disposal of li-censed material made under §§20.2002 (including burials au-thorized before January 28, 19811), 20.2003, 20.2004, 20.2005; and (2) Records required by §20.2103(b)(4). (f) Prior to license termination, each licensee shall forward the re-cords required by §30.35(g) to the appropriate NRC Regional Office. [41 FR 18301, May 5, 1976, as amended at 43 FR 6922, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 53 FR 19245, May 27, 1988; 58 FR 7736, Feb. 9, 1993; 61 FR 24673, May, 16, 1996] 1A previous §20.304 permitted burial of small quantities of li-censed materials in soil before January 28, 1981, without specific Commission authorization. See §20.304 contained in the 10 CFR, parts 0 to 199, edition revised as of January 1, 1981. §30.52 Inspections. (a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect by-product material and the premises and facilities wherein byproduct material is used or stored. (b) Each licensee shall make available to the Commission for inspection, upon reasonable notice, records kept by him pursuant to the regulations in this chapter. [30 FR 8185, June 26, 1965] §30.53 Tests. Each licensee shall perform, or permit the Commission to perform, such tests as the Commission deems appropriate or necessary for the administration of the regula-tions in this part and parts 31 through 36 and 39 of this chapter, including tests of: (a) Byproduct material; (b) Facilities wherein byproduct material is utilized or stored; (c) Radiation detection and monitoring instruments; and (d) Other equipment and devices used in connection with the utiliza-tion or storage of byproduct mate-rial. [30 FR 8185, June 26, 1965, as amended by 43 FR 6922, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993]


§30.55 Tritium reports. (a) - (b) [Reserved] (c) Except as specified in para-graph (d) of this section, each licen-see who is authorized to possess tritium shall report promptly to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter by telephone and tele-graph, mailgram, or facsimile any incident in which an attempt has been made or is believed to have been made to commit a theft or unlawful diversion of more than 10 curies of such material at any one time or more than 100 curies of such material in any one calendar year. The initial report shall be fol-lowed within a period of fifteen (15) days by a written report submitted to the appropriate NRC Regional Office which sets forth the details of the incident and its consequences. Copies of such written report shall be sent to the Director, Office of Nuclear Material Safety and Safe-guards, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Subsequent to the submis-sion of the written report required by this paragraph, the licensee shall promptly inform the Office of Nuclear Material Safety and Safe-guards by means of a written report of any substantive additional in-formation, which becomes available to the licensee, concerning an at-tempted or apparent theft or unlawful diversion of tritium. (d) The reports described in this section are not required for tritium possessed pursuant to a general license provided in part 31 of this chapter or for tritium contained in spent fuel. [37 FR 9208, May 6, 1972, as amended at 38 FR 1271, Jan. 11, 1973; 38 FR 2330, Jan. 24, 1973; 41 FR 16446, Apr. 19, 1976; 43 FR 6922, Feb. 17, 1978; 46 FR 55085, Nov. 6, 1981; 49 FR 24707, June 15, 1984; 52 FR 31611, Aug. 21, 1987]

Enforcement

§30.61 Modification and revoca-tion of licenses. (a) The terms and conditions of each license issued pursuant to the regulations in this part and parts 31 through 35 of this chapter shall be subject to amendment, revision or modification by reason of

amendments to the Act, or by rea-son of rules, regulations and orders issued in accordance with the terms of the Act. (b) Any license may be revoked, suspended or modified, in whole or in part, for any material false statement in the application or any statement of fact required under section 182 of the Act, or because of conditions revealed by such ap-plication or statement of fact or any report, record or inspection or other means which would warrant the Commission to refuse to grant a license on an original application, or for violation of, or failure to ob-serve any of the terms and provi-sions of the Act or of any rule, regulation or order of the Commis-sion. (c) Except in cases of willfulness or those in which the public health, interest or safety requires other-wise, no license shall be modified, suspended or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an oppor-tunity to demonstrate or achieve compliance with all lawful require-ments. [30 FR 8185, June 26, 1965, as amended at 35 FR 11460, July 17, 1970; 43 FR 6922, Feb. 17, 1978] §30.62 Right to cause the with-holding or recall of byproduct material. The Commission may cause the withholding or recall of byproduct material from any licensee who is not equipped to observe or fails to observe such safety standards to protect health as may be estab-lished by the Commission, or who uses such materials in violation of law or regulation of the Commis-sion, or in a manner other than as disclosed in the application therefor or approved by the Commission. [30 FR 8185, June 26, 1965, as amended at 40 FR 8785, Mar. 3, 1975] §30.63 Violations. (a) The Commission may obtain an injunction or other court order to prevent a violation of the provi-sions of --

(1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reor-ganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of -- (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or or-der issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limi-tation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under sec-tion 186 of the Atomic Energy Act of 1954, as amended. [57 FR 55072, Nov. 24, 1992] §30.64 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted viola-tion of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 30 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 30 that are not issued under sections 161b, 161i, or 161o for the pur-poses of section 223 are as follows: §§30.1, 30.2, 30.4, 30.5, 30.6, 30.8, 30.11, 30.12, 30.13, 30.15, 30.16, 30.31, 30.32, 30.33, 30.37, 30.38, 30.39, 30.61, 30.62, 30.63, 30.64, 30.70, 30.71, and 30.72. [57 FR 55072, Nov. 24, 1992]

Schedules

§30.70 Schedule A -- exempt concentrations. [See also Footnotes to Sched-ule A]


Footnotes to Schedule A 1.Values are given only for those materials normally used as gases. 2.µCi/gm for solids.

NOTE 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule A, the

activity stated is that of the parent isotope and takes into account the daughters.


NOTE 2: For purposes of 30.14 where there is involved a combina-tion of isotopes, the limit for the combination should be derived as follows: Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentra-tion established in Schedule A for the specific isotope when not in combination. The sum of such ra-tios may not exceed "1" (i.e., unity).Example:

[30 FR 8185, June 26, 1965, as amended at 35 FR 3982, Mar. 3, 1970; 38 FR 29314, Oct. 24, 1973; 59 FR 5520, Feb. 7, 1994]

[35 FR 6427, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 59 FR 5519, Feb. 7, 1994] §30.72 Schedule C -- Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release.


[54 FR 14061, Apr. 7, 1989, as amended at 61 FR 9902, Mar. 12, 1996] Appendix A to Part 30 -- Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assur-ance of Funds for Decommission-ing

I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decom-missioning based on obtaining a parent company guarantee that funds will be available for decom-missioning costs and on a demon-stration that the parent company passes a financial test. This appen-dix establishes criteria for passing the financial test and for obtaining the parent company guarantee. II. Financial Test A. To pass the financial test, the parent company must meet the criteria of either paragraph A.1 or A.2 of this section: 1. The parent company must have: (i) Two of the following three ratios: A ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depre-ciation, depletion, and amortization to total liabilities greater than 0.1; and a ratio of current assets to cur-rent liabilities greater than 1.5; and (ii) Net working capital and tan-gible net worth each at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or pre-scribed amount if a certification is used), or, for a power reactor licen-see, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof (Tangible net worth shall be calculated to exclude the net book value of the nuclear unit(s)); and (iii) Tangible net worth of at least $10 million; and (iv) Assets located in the United States amounting to at least 90 percent of the total assets or at least six times the current decom-missioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certifica-tion is used), or, for a power reactor licensee, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof. 2. The parent company must have: (i) A current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard


and Poor's or AAA, AA, A, or BAA as issued by Moody's; and (ii) Tangible net worth each at least six times the current decom-missioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certifica-tion is used), or, for a power reactor licensee, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof (Tangible net worth shall be calculated to exclude the net book value of the nuclear unit(s)); and (iii) Tangible net worth of at least $10 million; and (iv) Assets located in the United States amounting to at least 90 percent of the total assets or at least six times the current decom-missioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certifica-tion is used), or, for a power reactor licensee, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof. B. The parent company's inde-pendent certified public accountant must have compared the data used by the parent company in the fi-nancial test, which is derived from the independently audited, year end financial statements for the latest fiscal year, with the amounts in such financial statement. In con-nection with that procedure the licensee shall inform NRC within 90 days of any matters coming to the auditor's attention which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test. C. 1. After the initial financial test, the parent company must re-peat the passage of the test within 90 days after the close of each suc-ceeding fiscal year. 2. If the parent company no longer meets the requirements of paragraph A of this section, the licensee must send notice to the Commission of intent to establish alternate financial assurance as specified in the Commission's regu-lations. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year end financial data show

that the parent company no longer meets the financial test require-ments. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year. III. Parent Company Guarantee The terms of a parent company guarantee which an applicant or licensee obtains must provide that: A. The parent company guaran-tee will remain in force unless the guarantor sends notice of cancella-tion by certified mail to the licensee and the Commission. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Com-mission, as evidenced by the return receipts. B. If the licensee fails to provide alternate financial assurance as specified in the Commission's regu-lations within 90 days after receipt by the licensee and Commission of a notice of cancellation of the par-ent company guarantee from the guarantor, the guarantor will pro-vide such alternative financial as-surance in the name of the licensee. C. The parent company guaran-tee and financial test provisions must remain in effect until the Commission has terminated the license. D. If a trust is established for decommissioning costs, the trustee and trust must be acceptable to the Commission. An acceptable trustee includes an appropriate State or Federal Government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and exam-ined by a Federal or State agency. [53 FR 24046, June 27, 1988 as amended at 63 FR 50479, Sept. 22, 1998] Appendix B to Part 30 -- Quanti-ties1 of Licensed Material Requir-ing Labeling


Note: For purposes of §20.303, where there is involved a combina-tion of isotopes in known amounts, the limit for the combination should be derived as follows: De-termine, for each isotope in the combination, the ratio between the quantity present in the combina-tion and the limit otherwise estab-lished for the specific isotope when not in combination. The sum of such ratios for all the isotopes in the combination may not exceed "1" (i.e., "unity"). [35 FR 6425, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 38 FR 29314, Oct. 24, 1973; 39 FR 23991, June 28, 1974; 45 FR 71763, Oct. 30, 1980. Redesig-nated at 56 FR 23391, May 21, 1991, and further redesignated at 58 FR 67659, Dec. 22, 1993] Appendix C to Part 30 -- Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decom-missioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this appendix. The terms of the self-guarantee are in

Section III of this appendix. This appendix establishes criteria for passing the financial test for the self guarantee and establishes the terms for a self-guarantee. II. Financial Test A. To pass the financial test, a company must meet all of the fol-lowing criteria: (1) Tangible net worth at least 10 times the total current decom-missioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used), or, for a power reactor licensee, at least 10 times the amount of decommission-ing funds being assured by a self guarantee, for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor for the total of all reactor units or parts thereof (Tangible net worth shall be calculated to exclude the net book value of the nuclear unit(s)). (2) Assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current decommis-sioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certifi-cation is used), or, for a power re-actor licensee, at least 10 times the amount of decommissioning funds being assured by a self guarantee, for all decommissioning activities for which the company is responsi-ble as self-guaranteeing licensee and as parent-guarantor for the total of all reactor units or parts thereof. (3) A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys. B. To pass the financial test, a company must meet all of the fol-lowing additional requirements: (1) The company must have at least one class of equity securities registered under the Securities Ex-change Act of 1934. (2) The company's independent certified public accountant must have compared the data used by the company in the financial test which is derived from the inde-pendently audited, yearend finan-cial statements for the latest fiscal


year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform NRC within 90 days of any matters coming to the attention of the auditor that cause the audi-tor to believe that the data specified in the financial test should be ad-justed and that the company no longer passes the test. (3) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year. C. If the licensee no longer meets the requirements of Section II.A. of this appendix, the licensee must send immediate notice to the Commission of its intent to estab-lish alternate financial assurance as specified in the Commission's regulations within 120 days of such notice. III. Company Self-Guarantee The terms of a self-guarantee which an applicant or licensee fur-nishes must provide that: A. The guarantee will remain in force unless the licensee sends no-tice of cancellation by certified mail to the Commission. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Commission, as evidenced by the return receipt. B. The licensee shall provide alternative financial assurance as specified in the Commission's regu-lations within 90 days following receipt by the Commission of a no-tice of cancellation of the guaran-tee. C. The guarantee and financial test provisions must remain in ef-fect until the Commission has ter-minated the license or until another financial assurance method acceptable to the Commis-sion has been put in effect by the licensee. D. The licensee will promptly forward to the Commission and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commis-sion pursuant to the requirements of section 13 of the Securities and Exchange Act of 1934. E. If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A" or

above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to the Commission within 20 days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the licensee no longer meets the requirements of Section II.A. of this appendix. F. The applicant or licensee must provide to the Commission a written guarantee (a written com-mitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Com-mission, the licensee will set up and fund a trust in the amount of the current cost estimates for de-commissioning. [58 FR 68730, Dec. 29, 1993; 59 FR 1618, Jan. 12, 1994; 63 FR 50479, Sept. 22, 1998] Appendix D to Part 30--Criteria Relating To Use of Financial Tests and Self-Guarantee for Pro-viding Reasonable Assurance of Funds for Decommissioning by Commercial Companies That Have no Outstanding Rated Bonds I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decom-missioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix. This appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee. II. Financial Test A. To pass the financial test a company must meet the following criteria: (1) Tangible net worth greater than $10 million, or at least 10 times the total current decommis-sioning cost estimate (or the cur-rent amount required if certification is used), whichever is greater, for

all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor. (2) Assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current decommis-sioning cost estimate (or the cur-rent amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor. (3) A ratio of cash flow divided by total liabilities greater than 0.15 and a ratio of total liabilities di-vided by net worth less than 1.5. B. In addition, to pass the fi-nancial test, a company must meet all of the following requirements: (1) The company's independent certified public accountant must have compared the data used by the company in the financial test, which is required to be derived from the independently audited year end financial statement based on United States generally accepted accounting practices for the latest fiscal year, with the amounts in such financial statement. In con-nection with that procedure, the licensee shall inform NRC within 90 days of any matters that may cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test. (2) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year. (3) If the licensee no longer meets the requirements of para-graph II.A of this appendix, the li-censee must send notice to the NRC of intent to establish alterna-tive financial assurance as specified in NRC regulations. The notice must be sent by certified mail, re-turn receipt requested, within 90 days after the end of the fiscal year for which the year end financial data show that the licensee no longer meets the financial test re-quirements. The licensee must pro-vide alternative financial assurance within 120 days after the end of such fiscal year.


III. Company Self-Guarantee The terms of a self-guarantee which an applicant or licensee fur-nishes must provide that: A. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the NRC. Cancellation may not oc-cur until an alternative financial assurance mechanism is in place. B. The licensee shall provide alternative financial assurance as specified in the regulations within 90 days following receipt by the NRC of a notice of cancellation of the guarantee. C. The guarantee and financial test provisions must remain in ef-fect until the Commission has ter-minated the license or until another financial assurance method acceptable to the Commis-sion has been put in effect by the licensee. D. The applicant or licensee must provide to the Commission a written guarantee (a written com-mitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Com-mission, the licensee will set up and fund a trust in the amount of the current cost estimates for de-commissioning. Appendix E to Part 30--Criteria Relating to Use of Financial Tests and Self-Guarantee For Providing Reasonable Assurance of Funds For Decommissioning by Non-profit Colleges, Universities, and Hospitals I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decom-missioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the applicant or licensee passes the financial test of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix. This appendix estab-lishes criteria for passing the finan-cial test for the self-guarantee and establishes the terms for a self-guarantee.

II. Financial Test A. For colleges and universities, to pass the financial test a college or university must meet either the criteria in Paragraph II.A.(1) or the criteria in Paragraph II.A.(2) of this appendix. (1) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, un-collateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys. (2) For applicants or licensees that do not issue bonds, unre-stricted endowment consisting of assets located in the United States of at least $50 million, or at least 30 times the total current decom-missioning cost estimate (or the current amount required if certifi-cation is used), whichever is greater, for all decommissioning activities for which the college or university is responsible as a self-guaranteeing licensee. B. For hospitals, to pass the financial test a hospital must meet either the criteria in Paragraph II.B.(1) or the criteria in Paragraph II.B.(2) of this appendix: (1) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, un-collateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys. (2) For applicants or licensees that do not issue bonds, all the fol-lowing tests must be met: (a) (Total Revenues less total expenditures) divided by total reve-nues must be equal to or greater than 0.04. (b) Long term debt divided by net fixed assets must be less than or equal to 0.67. (c) (Current assets and deprecia-tion fund) divided by current liabili-ties must be greater than or equal to 2.55. (d) Operating revenues must be at least 100 times the total current decommissioning cost estimate (or the current amount required if cer-tification is used) for all decommis-sioning activities for which the hospital is responsible as a self-guaranteeing license.

C. In addition, to pass the fi-nancial test, a licensee must meet all the following requirements: (1) The licensee's independent certified public accountant must have compared the data used by the licensee in the financial test, which is required to be derived from the independently audited year end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in such financial state-ment. In connection with that pro-cedure, the licensee shall inform NRC within 90 days of any matters coming to the attention of the audi-tor that cause the auditor to believe that the data specified in the finan-cial test should be adjusted and that the licensee no longer passes the test. (2) After the initial financial test, the licensee must repeat passage of the test within 90 days after the close of each succeeding fiscal year. (3) If the licensee no longer meets the requirements of Section I of this appendix, the licensee must send notice to the NRC of its intent to establish alternative financial assurance as specified in NRC regulations. The notice must be sent by certified mail, return re-ceipt requested, within 90 days after the end of the fiscal year for which the year end financial data show that the licensee no longer meets the financial test require-ments. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year. III. Self-Guarantee The terms of a self-guarantee which an applicant or licensee fur-nishes must provide that-- A. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, and/or return receipt re-quested, to the Commission. Can-cellation may not occur unless an alternative financial assurance mechanism is in place. B. The licensee shall provide alternative financial assurance as specified in the Commission's regu-lations within 90 days following receipt by the Commission of a no-tice of cancellation of the guaran-tee.


C. The guarantee and financial test provisions must remain in ef-fect until the Commission has ter-minated the license or until another financial assurance method acceptable to the Commis-sion has been put in effect by the licensee. D. The applicant or licensee must provide to the Commission a written guarantee (a written com-mitment by a corporate officer or officer of the institution) which states that the licensee will fund and carry out the required decom-missioning activities or, upon issu-ance of an order by the Commission, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning. E. If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of ``A'' or above by either Standard and Poors or Moodys, the licensee shall provide notice in writing of such fact to the Commission within 20 days after publication of the change by the rating service. PART 31 -- GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL 31.1 Purpose and scope. 31.2 Terms and conditions. 31.3 Certain devices and equipment. 31.4 Information collection require-

ments: OMB approval. 31.5 Certain detecting, measuring,

gauging, or controlling devices and certain devices for producing light or an ionized atmosphere.

31.6 General license to install devices generally licensed in §31.5.

31.7 Luminous safety devices for use in aircraft.

31.8 Americium - 241 in the form of calibration or reference sources.

31.9 General license to own byprod-uct material.

31.10 General license for strontium 90 in ice detection devices.

31.11 General license for use of by-product material for certain in vitro clinical or laboratory testing.

31.12 Maintenance of records. 31.13 Violations. 31.14 Criminal penalties. Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42

U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842). Section 31.6 also issued under sec. 274, 73 Stat. 688 (42 U.S.C. 2021). §31.1 Purpose and scope. This part establishes general licenses for the possession and use of byproduct material and a general license for ownership of byproduct material. Specific provisions of 10 CFR Part 30 are applicable to gen-eral licenses established by this part. These provisions are specified in Sec. 31.2 or in the particular general license. §31.2 Terms and conditions. The general licenses provided in this part are subject to the general provisions of Part 30 of this chapter (Secs. 30.1 through 30.10), the provisions of Secs. 30.14(d), 30.34(a) to (e), 30.41, 30.50 to 30.53, 30.61 to 30.63, and Parts 19,20, and 21, of this chapter 1 unless indicated otherwise in the specific provision of the general license. 1Attention is directed particu-larly to the provisions of Part 20 of this chapter concerning labeling of containers. §31.3 Certain devices and equip-ment. A general license is hereby is-sued to transfer, receive, acquire, own, possess and use byproduct material incorporated in the follow-ing devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with the specifications contained in a specific license is-sued to him by the Commission. (a) Static elimination device. De-vices designed for use as static eliminators which contain, as a sealed source or sources, byprod-uct material consisting of a total of not more than 500 microcuries of polonium 210 per device. (b) - (c) [Reserved] (d) Ion generating tube. Devices designed for ionization of air which contain, as a sealed source or sources, byproduct material con-sisting of a total of not more than 500 microcuries of polonium 210 per device or of a total of not more

than 50 millicuries of hydrogen 3 (tritium) per device. [30 FR 8189, June 26, 1965, as amended at 34 FR 6652, Apr. 18, 1969; 35 FR 3982, Mar. 3, 1970] §31.4 Information collection re-quirements: OMB approval. ((a) The Nuclear Regulatory Commission has submitted the in-formation collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Pa-perwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a col-lection of information unless it dis-plays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0016. (b) The approved information collection requirements contained in this part appear in §§31.5, 31.6, 31.8, and 31.11. (c) This part contains informa-tion collection requirements in ad-dition to those approved under the control number specified in para-graph (a) of this section. These in-formation collection requirements and the control numbers under which they are approved are as fol-lows: (1) In §31.11, NRC Form 483 is approved under control number 3150-0038. (2) [Reserved] [62 FR 52186, Oct. 6, 1997] §31.5 Certain detecting, measur-ing, gauging, or controlling de-vices and certain devices for producing light or an ionized at-mosphere.(2) (a) A general license is hereby issued to commercial and indus-trial firms and research, educa-tional and medical institutions, individuals in the conduct of their business, and Federal, State or lo-cal government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of paragraphs (b), (c) and (d) of this section, byproduct material con-tained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leak-


age, or qualitative or quantitative chemical composition, or for pro-ducing light or an ionized atmos-phere. (b)(1) The general license in paragraph (a) of this section applies only to byproduct material con-tained in devices which have been manufactured or initially trans-ferred and labeled in accordance with the specifications contained in-- (i) A specific license issued un-der Sec. 32.51 of this chapter; or (ii) An equivalent specific license issued by an Agreement State. (2) The devices must have been received from one of the specific licensees described in paragraph (b)(1) of this section or through a transfer made under paragraph (c)(9) of this section. (c) Any person who acquires, receives, possesses, uses or trans-fers byproduct material in a device pursuant to the general license in paragraph (a) of this section: (1) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohib-ited are maintained thereon and shall comply with all instructions and precautions provided by such labels; (2) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indica-tor, if any, at no longer than six-month intervals or at such other intervals as are specified in the la-bel; however: (i) Devices containing only kryp-ton need not be tested for leakage of radioactive material, and (ii) Devices containing only trit-ium or not more than 100 micro-curies of other beta and/or gamma emitting material or 10 microcuries of alpha emitting material and de-vices held in storage in the original shipping container prior to initial installation need not be tested for any purpose; (3) Shall assure that the tests required by paragraph (c)(2) of this section and other testing, installa-tion, servicing, and removal from installation involving the radioac-tive materials, its shielding or con-tainment, are performed:

(i) In accordance with the in-structions provided by the labels; or (ii) By a person holding a spe-cific license pursuant to parts 30 and 32 of this chapter or from an Agreement State to perform such activities; (4) Shall maintain records show-ing compliance with the require-ments of paragraphs (c)(2) and (c)(3) of this section. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, install-ing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these re-cords as follows: (i) Each record of a test for leak-age or radioactive material required by paragraph (c)(2) of this section must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of. (ii) Each record of a test of the on-off mechanism and indicator required by paragraph (c)(2) of this section must be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of. (iii) Each record that is required by paragraph (c)(3) of this section must be retained for three years from the date of the recorded event or until the device is transferred or disposed of. (5) Shall immediately suspend operation of the device if there is a failure of, or damage to, or any in-dication of a possible failure of or damage to, the shielding of the ra-dioactive material or the on-off mechanism or indicator, or upon the detection of 185 bequerel (0.005 microcurie) or more remov-able radioactive material. The de-vice may not be operated until it has been repaired by the manufac-turer or other person holding a specific license to repair such de-vices that was issued under parts 30 and 32 of this chapter or by an Agreement State. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the by-product material in the device or as

otherwise approved by the Com-mission. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 micro-curie or more removable radioactive material or failure of or damage to a source likely to result in contami-nation of the premises or the envi-rons, a plan for ensuring that the premises and environs are accept-able for unrestricted use, must be furnished to the Director of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regula-tory Commission, Washington, DC 20555-0001 within 30 days. Under these circumstances, the criteria set out in Sec. 20.1402, ``Radio-logical criteria for unrestricted use,'' may be applicable, as deter-mined by the Commission on a case-by-case basis; (6) Shall not abandon the device containing byproduct material; (7) Shall not export the device containing byproduct material ex-cept in accordance with part 110 of this chapter; (8)(i) Shall transfer or dispose of the device containing byproduct material only by export as provided by paragraph (c)(7) of this section, by transfer to another general li-censee as authorized in paragraph (c)(9) of this section, or to a person authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter, or part 30 of this chapter that author-izes waste collection, or equivalent regulations of an Agreement State, or as otherwise approved under paragraph (c)(8)(iii) of this section. (ii) Shall furnish a report to the Director of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days after the transfer of a device to a specific licensee or export. The report must contain-- (A) The identification of the de-vice by manufacturer's (or initial transferor's) name, model number, and serial number; (B) The name, address, and li-cense number of the person receiv-ing the device (license number not applicable if exported); and (C) The date of the transfer. (iii) Shall obtain written NRC approval before transferring the device to any other specific licensee


not specifically identified in para-graph (c)(8)(i) of this section. (9) Shall transfer the device to another general licensee only if-- (i) The device remains in use at a particular location. In this case, the transferor shall give the trans-feree a copy of this section, a copy of Secs. 31.2, 30.51, 20.2201, and 20.2202 of this chapter, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to the Director of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regula-tory Commission, Washington, DC 20555-0001-- (A) The manufacturer's (or initial transferor's) name; (B) The model number and the serial number of the device trans-ferred; (C) The transferee's name and mailing address for the location of use; and (D) The name, title, and phone number of the responsible individ-ual identified by the transferee in accordance with paragraph (c)(12) of this section to have knowledge of and authority to take actions to ensure compliance with the appro-priate regulations and require-ments; or (ii) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee. (10) Shall comply with the pro-visions of §§20.2201, and 20.2202 of this chapter for reporting radia-tion incidents, theft or loss of li-censed material, but shall be exempt from the other require-ments of parts 19, 20, and 21, of this chapter. (11) Shall respond to written requests from the Nuclear Regula-tory Commission to provide infor-mation relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by submitting a letter to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washing-

ton, DC 20555-0001 and provide written justification as to why it cannot comply. (12) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall en-sure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard. (13)(i) Shall register, in accor-dance with paragraphs (c)(13)(ii) and (iii) of this section, devices con-taining at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, or 37 MBq (1 mCi) of americium-241 or any other tran-suranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label. Each address for a loca-tion of use, as described under paragraph (c)(13)(iii)(D) of this sec-tion, represents a separate general licensee and requires a separate registration and fee. (ii) If in possession of a device meeting the criteria of paragraph (c)(13)(i) of this section, shall regis-ter these devices annually with the Commission and shall pay the fee required by Sec. 170.31 of this chapter. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration re-ceived from the Commission. The registration information must be submitted to the NRC within 30 days of the date of the request for registration or as otherwise indi-cated in the request. In addition, a general licensee holding devices meeting the criteria of paragraph (c)(13)(i) of this section is subject to the bankruptcy notification re-quirement in Sec. 30.34(h) of this chapter. (iii) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Commission-- (A) Name and mailing address of the general licensee.

(B) Information about each de-vice: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activ-ity (as indicated on the label). (C) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under para-graph (c)(12) of this section. (D) Address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage. (E) Certification by the respon-sible representative of the general licensee that the information con-cerning the device(s) has been veri-fied through a physical inventory and checking of label information. (F) Certification by the responsi-ble representative of the general licensee that they are aware of the requirements of the general license. (iv) Persons generally licensed by an Agreement State with respect to devices meeting the criteria in paragraph (c)(13)(i) of this section are not subject to registration re-quirements if the devices are used in areas subject to NRC jurisdiction for a period less than 180 days in any calendar year. The Commission will not request registration infor-mation from such licensees. (14) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the Director of Nuclear Material Safety and Safe-guards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washing-ton, DC 20555-0001 within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the de-vice's primary place of storage. (15) May not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only. However, when de-vices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested be-


fore use. Devices kept in standby for future use are excluded from the two-year time limit if the gen-eral licensee performs quarterly physical inventories of these de-vices while they are in standby. (d) The general license in para-graph (a) of this section does not authorize the manufacture or im-port of devices containing byprod-uct material. 2Persons possessing byproduct material in devices under a general license in Sec. 31.5 before January 15, 1975, may continue to possess, use, or transfer that material in accordance with the labeling re-quirements of Sec. 31.5 in effect on January 14, 1975. §31.6 General license to install devices generally licensed in §31.5. Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, install, or service a device described in §31.5 within such Agreement State is hereby granted a general license to install and service such device in any non-Agreement State and a general li-cense to install and service such device in offshore waters, as de-fined in §150.3(f) of this chapter: Provided, That: (a) [Reserved] (b) The device has been manu-factured, labeled, installed, and serviced in accordance with appli-cable provisions of the specific li-cense issued to such person by the Agreement State. (c) Such person assures that any labels required to be affixed to the device under regulations of the Agreement State which licensed manufacture of the device bear a statement that removal of the label is prohibited. [30 FR 8189, June 26, 1965, as amended at 30 FR 10947, Aug. 24, 1965; 39 FR 43533, Dec. 16, 1974; 46 FR 44151, Sept. 3, 1981] §31.7 Luminous safety devices for use in aircraft. (a) A general license is hereby issued to own, receive, acquire, possess, and use tritium or prome-thium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 10 curies of tritium or

300 millicuries of promethium-147 and that each device has been manufactured, assembled or ini-tially transferred in accordance with a license issued under the provisions of §32.53 of this chapter or manufactured or assembled in accordance with a specific license issued by an Agreement State which authorizes manufacture or assembly of the device for distribu-tion to persons generally licensed by the Agreement State. (b) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the gen-eral license in this section are ex-empt from the requirements of parts 19, 20, and 21, of this chap-ter, except that they shall comply with the provisions of §§20.2201, and 20.2202 of this chapter. (c) This general license does not authorize the manufacture, assem-bly, repair or import of luminous safety devices containing tritium or promethium-147. (d) This general license does not authorize the export of luminous safety devices containing tritium or promethium-147. (e) This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in in-strument dials. [30 FR 8189, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 38 FR 22220, Aug. 17, 1973; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, Dec. 22, 1993] §31.8 Americium-241 in the form of calibration or reference sources. (a) A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use and transfer, in accordance with the provisions of paragraphs (b) and (c) of this section, ameri-cium-241 in the form of calibration or reference sources: (1) Any person in a non-Agreement State who holds a spe-cific license issued pursuant to this chapter which authorizes him to receive, possess, use and transfer byproduct material, source mate-rial, or special nuclear material; and

(2) Any Government agency, as defined in §30.4(g) of this chapter, which holds a specific license is-sued pursuant to this chapter which authorizes it to receive, pos-sess, use and transfer byproduct material, source material, or special nuclear material. (b) The general license in para-graph (a) of this section applies only to calibration or reference sources which have been manufac-tured or initially transferred in ac-cordance with the specifications contained in a specific license is-sued pursuant to §32.57 of this chapter or in accordance with the specifications contained in a spe-cific license issued to the manufac-turer by an Agreement State which authorizes manufacture of the sources for distribution to persons generally licensed by the Agreement State. (c) The general license in para-graph (a) of this section is subject to the provisions of §§30.14(d), 30.34 (a) to (e), and 30.50 to 30.63 of this chapter, and to the provi-sions of parts 19, 20, and 21, of this chapter. In addition, persons who own, receive, acquire, possess, use and transfer one or more cali-bration or reference sources pursu-ant to this general license: (1) Shall not possess at any one time, at any one location of storage or use, more than 5 microcuries of americium-241 in such sources: (2) Shall not receive, possess, use or transfer such source unless the source, or the storage con-tainer, bears a label which includes the following statement or a sub-stantially similar statement which contains the information called for in the following statement:(1) The receipt, possession, use and transfer of this source, Model XX, Serial No. XX, are subject to a gen-eral license and the regulations of the United States Nuclear Regula-tory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not re-move this label. CAUTION -- RADIOACTIVE MATERIAL -- THIS SOURCE CONTAINS AMERICIUM-241. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. (Name of manufacturer or initial transferor)


(3) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license pursuant to this chapter or from an Agreement State to receive the source. (4) Shall store such source, ex-cept when the source is being used, in a closed container adequately designed and constructed to con-tain americium - 241 which might otherwise escape during storage. (5) Shall not use such source for any purpose other than the calibra-tion of radiation detectors or the standardization of other sources. (d) This general license does not authorize the manufacture or im-port of calibration or reference sources containing americium-241. (e) This general license does not authorize the export of calibration or reference sources containing americium-241. [30 FR 8189, June 26, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978; 56 FR 40767, Aug. 16, 1991] 1Sources generally licensed un-der this section prior to January 19, 1975 may bear labels author-ized by the regulations in effect on January 1, 1975. §31.9 General license to own by-product material. A general license is hereby is-sued to own byproduct material without regard to quantity. Not-withstanding any other provision of this chapter, a general licensee un-der this paragraph is not author-ized to manufacture, produce, transfer, receive, possess, use, im-port or export byproduct material, except as authorized in a specific license. [30 FR 8189, June 26, 1965] §31.10 General license for stron-tium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer stron-tium 90 contained in ice detection devices, provided each device con-tains not more than fifty micro-curies of strontium 90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to §32.61

of this chapter or in accordance with the specifications contained in a specific license issued to the manufacturer by an Agreement State which authorizes manufac-ture of the ice detection devices for distribution to persons generally licensed by the Agreement State. (b) Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice de-tection devices pursuant to the general license in paragraph (a) of this section: (1) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license pursuant to part 30 or 32 of this chapter or from an Agreement State to manu-facture or service such devices; or shall dispose of the device pursu-ant to the provisions of §20.2001. (2) Shall assure that all labels affixed to the device at the time of receipt, and which bear a state-ment which prohibits removal of the labels, are maintained thereon; (3) Are exempt from the re-quirements of parts 19, 20, and 21, of this chapter except that such persons shall comply with the pro-visions of §§20.2001, 20.2201, and 20.2202 of this chapter. (c) The general license does not authorize the manufacture, assem-bly, disassembly, repair, or import of strontium 90 in ice detection devices. [30 FR 9905, Aug. 10, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, Dec. 22, 1993] §31.11 General license for use of byproduct material for certain in vitro clinical or laboratory test-ing. (a) A general license is hereby issued to any physician, veterinar-ian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, pos-sess, transfer, or use, for any of the following stated tests, in accor-dance with the provisions of para-

graphs (b), (c), (d), (e), and (f) of this section, the following byproduct materials in prepackaged units: (1) Iodine-125, in units not ex-ceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or ex-ternal administration of byproduct material, or the radiation there-from, to human beings or animals. (2) Iodine-131, in units not ex-ceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or ex-ternal administration of byproduct material, or the radiation there-from, to human beings or animals. (3) Carbon-14, in units not ex-ceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or ex-ternal administration of byproduct material, or the radiation there-from, to human beings or animals. (4) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not involving inter-nal or external administration of byproduct material, or the radiation therefrom, to human beings or animals. (5) Iron-59, in units not exceed-ing 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct mate-rial, or the radiation therefrom, to human beings, or animals. (6) Selenium-75, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or ex-ternal administration of byproduct material, or the radiation there-from, to human beings or animals. (7) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of io-dine-129 and 0.005 microcurie of americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external ad-ministration of byproduct material, or the radiation therefrom, to hu-man beings or animals. (b) A person shall not receive, acquire, possess, use, or transfer byproduct material under the gen-eral license established by para-graph (a) of this section unless that person: (1) Has filed Form NRC - 483, "Registration Certificate -- In Vitro


Testing with Byproduct Material Under General License," with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washing-ton, DC 20555 and received from the Commission a validated copy of Form NRC - 483 with a registration number assigned; or (2) Has a license that authorizes the medical use of byproduct mate-rial that was issued under part 35 of this chapter. (c) A person who receives, ac-quires, possesses, or uses byprod-uct material pursuant to the general license established by paragraph (a) of this section shall comply with the following: (1) The general licensee shall not possess at any one time, pursuant to the general license in paragraph (a) of this section, at any one loca-tion of storage or use, a total amount of iodine 125, iodine 131, selenium-75, and/or iron-59 in excess of 200 microcuries. (2) The general licensee shall store the byproduct material, until used, in the original shipping con-tainer or in a container providing equivalent radiation protection. (3) The general licensee shall use the byproduct material only for the uses authorized by paragraph (a) of this section. (4) The general licensee shall not transfer the byproduct material except by transfer to a person au-thorized to receive it by a license pursuant to this chapter or from an Agreement State, nor transfer the byproduct material in any manner other than in the unopened, labeled shipping container as received from the supplier. (5) The general licensee shall dispose of the Mock Iodine-125 ref-erence or calibration sources de-scribed in paragraph (a)(7) of this section as required by §20.2001. (d) The general licensee shall not receive, acquire, possess, or use byproduct material pursuant to paragraph (a) of this section: (1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of §32.71 of this chapter or in ac-cordance with the provisions of a specific license issued by an Agreement State that authorizes manufacture and distribution of

iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, or Mock Iodine-125 for distribution to persons generally licensed by the Agreement State. (2) Unless the following state-ment, or a substantially similar statement which contains the in-formation called for in the following statement, appears on a label af-fixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:(1) This radioactive material may be received, acquired, possessed, and used only by physicians, veteri-narians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clini-cal or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. (Name of Manufacturer) (e) The registrant possessing or using byproduct materials under the general license of paragraph (a) of this section shall report in writ-ing to the Director of Nuclear Mate-rial Safety and Safeguards, any changes in the information fur-nished by him in the "Registration Certificate -- In Vitro Testing With Byproduct Material Under General License". Form NRC - 483. The re-port shall be furnished within 30 days after the effective date of such change. (f) Any person using byproduct material pursuant to the general license of paragraph (a) of this sec-tion is exempt from the require-ments of parts 19, 20, and 21, of this chapter with respect to by-product materials covered by that general license, except that such persons using the Mock Iodine-125 described in paragraph (a)(7) of this section shall comply with the provi-sions of §§20.2001, 20.2201, and 20.2202. [33 FR 16553, Nov. 14, 1968, as amended at 38 FR 1271, Jan. 11, 1973; 38 FR 34110, Dec. 11, 1973; 39 FR 26147, July 17, 1974; 40 FR 8785, Mar. 3, 1975; 41 FR 16446,

Apr. 19, 1976; 42 FR 21604, Apr. 28, 1977; 42 FR 26987, May 26, 1977; 42 FR 28896, June 6, 1977; 44 FR 50325, Aug. 28, 1979; 51 FR 36967, Oct. 16, 1986; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, Dec. 22, 1993] 1Labels authorized by the regu-lations in effect on September 26, 1979, may be used until one year from September 27, 1979. §31.12 Maintenance of records. Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenti-cated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in elec-tronic media with the capability for producing legible, accurate, and complete records during the re-quired retention period. Records such as letters, drawings, specifica-tions, must include all pertinent information such as letters, stamps, initials, and signatures. The licensee shall maintain ade-quate safeguards against tampering with and loss of records. [53 FR 19246, May 27, 1988] §31.13 Violations. (a) The Commission may obtain an injunction or other court order to prevent a violation of the provi-sions of -- (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reor-ganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of -- (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or or-der issued pursuant to the sections


specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limi-tation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under sec-tion 186 of the Atomic Energy Act of 1954, as amended. [57 FR 55072, Nov. 24, 1992] §31.14 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted viola-tion of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 31 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 31 that are not issued under sections 161b, 161i, or 161o for the pur-poses of section 223 are as follows: §§31.1, 31.2, 31.3, 31.4, 31.9, 31.13, and 31.14. [57 FR 55073, Nov. 24, 1992]

Appendix C Technical Paper

C-1

Reprinted from J. Aerosol Sci., Volume 19, No. 3, A. Wiedensohler, “An Approximation of the Bipolar Charge Distribution for Particles in the Submicron Size Range,” pp. 387–389, Copyright 1988, with permission from Pergamon Press Ltd, Headington Hill Hall, Oxford OX3 OBW, UK. Note: Substitute Table C-1 for Table 1 in the Wiedensohler paper.

Table 1 is corrected based on correspondence with Wiedensoh-ler, with the changes highlighted in bold type.

Table C-1 Approximation Coefficient ai(N)

N ai(N) –2 –1 0 1 2

a0 –26.3328 –2.3197 –0.0003 –2.3484 –44.4756 a1 35.9044 0.6175 –0.1014 0.6044 79.3772 a2 –21.4608 0.6201 0.3073 0.4800 –62.8900 a3 7.0867 –0.1105 –0.3372 0.0013 26.4492 a4 –1.3088 –0.1260 0.1023 –0.1553 –5.7480 a5 0.1051 0.0297 –0.0105 0.0320 0.5049

C-2 Model 3077/3077A Aerosol Neutralizers

Technical Paper C-3

Technical Paper C-5

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