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15A NCAC 11 .1627
Receipt of Packages
Containing Radioactive Material:
The agency requires that licensees who receive packages
marked as containing radioactive materials in the type, form, and quantity prescribed in
this regulation perform receipt surveys on the packages to ensure that no contamination is
being brought into a facility and that if contamination is found, the final carrier and
the agency are notified.
What regulations
are applicable?
There are a several regulations and definitions relative to the "receipt of
packages" regulation (15A NCAC 11 .1627). Those definitions and regulations are
outlined below:
| .0104 DEFINITIONS |
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(96) |
"Radioactive material" means any material,
solid, liquid. or gas, which emits radiation spontaneously.
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(121) |
"Special form radioactive
material" means radioactive material which satisfies the following conditions:
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(a) |
It is either a single solid piece or is contained in a sealed capsule that can be
opened only by destroying the capsule;
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(b) |
The piece or capsule has at least one dimension not less than five millimeters
(0.197 inch); and
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(c) |
It satisfies the test requirements specified by the U. S. Nuclear Regulatory
Commission, subpart F of 10 CFR Part 71, and tests described in Rule .0114 of this
Section. A special form encapsulation designed in accordance with the U. S.
Nuclear Regulatory Commission requirements in effect on June 30, 1984, and
constructed prior to July 1, 1985, may continue to be used. A special form
encapsulation either designed or constructed after June 30, 1985, must meet the
requirements of this definition applicable at the time of its design or construction.
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(131) |
"Type A quantity" means a
quantity of radioactive material, the aggregate radioactivity of which does not exceed A1
for special form radioactive material or A2 for normal form radioactive
material, where A1 and A2 are given in Rule .0113 of this Section or
may be determined by procedures described in Rule .0113 of this Section. All
quantities of radioactive material greater than Type A are Type B.
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| .1627
PROCEDURES FOR RECEIVING AND OPENING PACKAGES [Effective August, 2002] |
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(a) |
Each licensee who
expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as Defined in Rule .0104 of this Chapter, shall make
arrangements to receive:
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(1) |
the package when the carrier offers
it for delivery; or |
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(2) |
notification of the arrival of the
package at the carrier's terminal and to take possession of the package expeditiously.
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(b) |
Each licensee, upon
receipt of a package containing radioactive material, shall monitor: |
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(1) |
external surfaces of a package
labeled as containing radioactive material for radioactive contamination unless the
package contains only radioactive material in the form of a gas or in special
form as defined in 10 C.F.R. 71.4;
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(2) |
external surfaces of a package
labeled as containing radioactive materials for radiation levels unless the package
contains quantities of radioactive materials that are less than or equal to the Type A quantity, as defined in 10 C.F.R. 71.4 and Appendix A to Part
71; and
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(3) |
all packages known to contain
radioactive materiel for radioactive contamination and radiation levels if there is
evidence of degradation of package integrity, such as packages that are crushed, wet, or
damaged.
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(c) |
The licensee shall perform the monitoring required by
Paragraph (b) of this Rule as soon as practicable after receipt of the package, but not
later than three 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 three hours from
the beginning of the next working day if it is received after working hours.
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(d) |
The licensee shall immediately notify the final delivery carrier
and, by telephone and telegram, mailgram, or facsimile, the agency when: |
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(1) |
removable radioactive surface
contamination exceeds the limits in 10 § CFR 71.87(i); or
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(2) |
external radiation levels exceed the
limits of 10 § CFR 71.47
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(e) |
Each licensee shall: |
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(1) |
establish, maintain, and retain
written procedures for safely opening packages in which radioactive material is received;
and
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(2) |
ensure that the procedures are
followed and that due consideration is given to special instructions for the type of
package being opened.
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(f) |
Licensees transferring special form sources in licensee-owned or licensee-operated vehicles
to and from a work site are exempt from the contamination requirements of Paragraph (b) of
this Rule, but are not exempt from the survey requirement in Paragraph (b) of this Rule
for measuring radiation levels that is required to ensure that the source is still
properly lodged in its shield. |
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Return to .1627 questions |
What surveys are REQUIRED to be performed when
packages are received?
15A NCAC 11 .1627(b) defines the receipt surveys which are
required by the regulation. The three (3) subparts are as follows:
| (1) |
REMOVABLE CONTAMINATION
surveys shall be conducted on ALL packages labeled as containing
radioactive materials UNLESS the radioactive material is in the
form of GAS or it is in SPECIAL FORM as defined above. |
| (2) |
EXPOSURE RATE surveys shall be done for ALL
packages which contain GREATER THAN TYPE A quantities of radioactive
materials. This means that if you receive a PACKAGE LABELED AS TYPE B, you have to
perform an exposure rate survey (and document it!). Most licensees will not have to
perform and document the exposure rate survey. For example, the A2 value
for 99mTc is 216 Curies. If you receive a total of 3 curies in unit
doses and "bulk tech" per day, then you do not have to perform an exposure rate
survey on the incoming package(s). (click here for A1/A2 Table from 49 CFR) |
| (3) |
REMOVABLE CONTAMINATION AND EXPOSURE RATE
surveys SHALL be done on ALL PACKAGES WHICH PACKAGE INTEGRITY APPEARS TO BE
COMPROMISED. This means crushed, wet, unsealed, dented, etc. |
So, surveys have to be done in the following circumstances:
1. You MUST
do removable contamination surveys on all packages labeled as containing radioactive
material UNLESS the contain only GAS or SPECIAL FORM
sources;
2. Licensees MUST
perform an exposure rate survey when receiving a package containing GREATER THAN TYPE A (e.g TYPE B) quantities of radioactive
mateials;
3. IF IT LOOKS DAMAGED, DO BOTH
EXPOSURE RATE AND REMOVABLE CONTAMINATION SURVEYS.
Return to .1627
questions
Time Lines for package
receipt
Ideally, packages will be checked in and surveyed
immediately upon receipt. The regulation provides for the receipt survey to occur
within three (3) hours of receipt if the package is received during NORMAL WORK HOURS.
If it is received outside of normal working hours (i.e., a drop-off by a nuclear
pharmacy at 04:30 am), the the receipt must occur WITHIN THREE (3) HOURS
from the time that NORMAL WORK HOURS begin (i.e., if work begins at
7:00 am, surveys must be completed by 10:00 am).
What are the limits
described in subparagraph (d) of the rule?
The limits described in subparagraph (d) of this rule deal
with external radiation levels and removable contamination levels as referenced in the
Code of Federal Regulations, Title 10, Part 71. These levels (actually limits) are
also described in 49 CFR 173.441 and 173.443 and are as follows:
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RADIATION LEVEL LIMITS |
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The package cannot exceed 200
millirem per hour (200 mrem/hr) on CONTACT with ANY
package surface or more than 10 millirem per hour (10 mrem/hr) at ONE METER
from any surface of the package.
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CONTAMINATION LIMITS |
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The package cannot have more than
22 dpm/cm2 of removable beta, gamma or low toxicity alpha emitters or more than
2.2 dpm/cm2 for all other alpha emitting radionuclides. |
Return
to .1627 questions
Are action levels for
notification of the RSO required by regulation or agency policy?
No, there are no regulations which explicitly require a
licensee to establish action levels for RSO notification for package receipt surveys.
However, the agency does support such efforts and deems these practices to be
consistent with the ALARA principles established in the regulations. The
establishment of "action levels" for RSO notification should be set well below
the limits referenced above. Typically, these "action levels" are set 5
times lower than the limits referenced above (i.e., a package > 2 mrem/hr at one meter
or > 40 mrem/hr on contact).
If the licensee makes a decision to implement "action
levels" then due consideration should be given to the type of packages received (e.g.
Yellow II or Yellow III) and the levels should be set accordingly. Again, the agency
does not require that any package receipt "action levels" be set.
What does subparagraph (f)
mean?
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(f) |
Licensees transferring special form
sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt
from the contamination requirements of Paragraph (b) of this Rule, but are not exempt from
the survey requirement in Paragraph (b) of this Rule for measuring radiation levels that
is required to ensure that the source is still properly lodged in its shield. |
The exemption for special form sources (notice that this
rule is NOT talking about sealed sources in general) is given because of
the extremely low probability of leakage from a sealed source that has been classified as
"special form." The licensee still has to perform the surveys for
radiation levels at one meter AND on
contact with the package to ensure compliance. Additionally, the mode of
transportation MUST be a licensee-owned or
licensee-operated vehicle AND the
package must be in route to and/or from a work site.
Return
to .1627 questions
To whom does subparagraph (f)
apply?
It applies to the licensees who routinely transport special
form sources to and from work sites. These are usually industrial radiography,
wireline (well logging), and portable nuclear gauge licensees. This subparagraph DOES NOT APPLY to everyone who transports sealed sources.
Return
to .1627 questions
What policies/procedures must I have in
place and what areas should be addressed for licensing purposes?
At a minimum, the licensees policies/procedures should
address the following:
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1. |
Instrumentation for measurement of the
radiation levels (give window thickness, sensitivity, type(s) of radiation detected,
etc.); |
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2. |
Instrumentation for measurement of the
removable contamination levels (give minimum detectable levels, efficiency, discuss
geometry for counting, etc.) |
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3. |
Record keeping requirements specified in
.1627(e); |
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4. |
Procedure for the notifications required in
.1627(d) (i.e., agency telephone/facsimile numbers, carrier telephone/facsimile numbers,
etc.); |
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5. |
Trigger levels for notification of the
radiation safety officer (usually much lower than the limits in .1627(d)); |
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6. |
Procedures for isolating the package if
radiation or removable contamination levels exceed the limits in .1627(d); |
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Return
to .1627 questions
What instrumentation
for determining removable contamination is (are) required?
The selection of instrumentation to determine compliance
with the removable contamination is left up to the individual licensee. However, the
agency will require that the following conditions concerning the equipment be met:
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1. |
Fixed geometry for counting the wipe samples.
This ensures consistency with the counts from day to day and for comparison to the
background or efficiency counts; |
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Efficiency of detection must be addressed; |
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Correction factors based upon the efficiency,
etc.; |
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Proper technique for counting the sample; |
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