| 15A NCAC 11 .1610
Declared Pregnant Worker
& Dose to an Embryo/Fetus:
In order to comply with the provisions of
15A NCAC 11 .1610, there must be a policy/procedure in place to address the issues
concerning declared pregnancies and fetal doses. The policy should be limited to
discussions of radiation safety, not internal policies which have no bearing on
radiation
safety (i.e., ...the worker may at this time be moved to another position...).
Statements such as these tend to confuse this issue and may result in the agency finding
your policy/procedures incompatible with the regulations.
What issues
and regulations should be considered when developing a pregnant worker/fetal dose policy?
There are a several regulations and definitions which must be considered when a licensee
is developing a declared pregnant worker policy. Those definitions and regulations
are outlined below:
| .0104 DEFINITIONS |
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(28) |
"Declared pregnant woman" means a woman who has voluntarily informed
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.
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(42) |
"Embryo/fetus" means the developing human organism from conception
until the time of birth.
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| .1610
DOSE TO AN EMBRYO/FETUS |
|
(a) |
The licensee or
registrant shall ensure that the dose equivalent to an embryo/fetus during the entire
pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5
rem (5 mSv). Recordkeeping requirements for doses to an embryo/fetus are provided
in Rule .1640 of this Section.
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(b) |
The licensee or
registrant shall make efforts to avoid substantial variation above a uniform monthly
exposure rate to a declared pregnant woman so as to satisfy the limit in Paragraph (a) of
this Rule.
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(c) |
The dose equivalent to
an embryo/fetus shall be taken as the sum of: |
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|
(1) |
the deep dose equivalent to the
declared pregnant woman; and |
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(2) |
the dose equivalent to the
embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared
pregnant woman.
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(d) |
If the dose equivalent
to the embryo/fetus is found to have exceeded 0.45 rem (4.5 mSv) by the time the woman
declares the pregnancy to the licensee or registrant, the licensee or registrant shall be
deemed to be in compliance with Paragraph (a) of this Rule if the additional dose the the
embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
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.1614
MONITORING OF EXTERNAL AND INTERNAL OCCUPATIONAL DOSE
Each licensee or registrant shall monitor exposures to radiation and radioactive
material at levels sufficient to demonstrate compliance with the
occupational dose limits
of this Section. As a minimum: |
|
(1) |
Each licensee or
registrant shall monitor occupational exposure to radiation and shall supply and require
the use of individual monitoring devices by:.
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|
(a) |
adults likely to receive, in one
year from sources external to the body, a dose in excess of 10 percent of the limits in
Rule .1604(a) of this Section; |
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(b) |
minors likely to receive, in one
year, from sources of radiation, a deep dose equivalent 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 of 0.5
rem (5 mSv).
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(c) |
declared pregnant women likely to
receive, during the entire pregnancy, from sources of radiation external to the body, a
deep dose equivalent in excess of 0.1 rem (1 mSv); and |
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(d) |
individuals entering a high or very
high radiation area. |
|
(2) |
Each licensee shall
monitor the occupational intake of radioactive materials by and assess the committed
effective dose equivalent to:
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|
(a) |
adults likely to receive, in one
year, an intake in excess of 10 percent of the applicable ALI(s) in Table I, Columns 1 and
2, of Appendix B to 10 CFR 20.1001 - 20.2402; and, |
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(b) |
minors and declared pregnant women
likely to receive, in one year, a committed effective dose equivalent in excess of 0.1 rem
(1 mSv).
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| .1640
RECORDS OF INDIVIDUAL MONITORING RESULTS |
|
(a) |
Each licensee or
registrant shall maintain records of doses received by all individuals for whom monitoring
was required pursuant to Rule .1614 of this Section, and records of doses received during
planned special exposures, accidents, and emergency conditions. These records shall
include, when applicable:
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(1) |
the deep-dose equivalent to the
whole body, eye dose equivalent, shallow-dose equivalent to the skin, and shallow-dose
equivalent to the extremities; |
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(2) |
the estimated intake of
radionuclides (see Rule .1605 of this Section); |
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(3) |
the committed effective dose
equivalent assigned to the intake or body burden of radionuclides; |
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(4) |
the specific information used to
calculate the committed effective dose equivalent pursuant to Rule .1607(c) of this
Section and when required by Rule .1614 of this Section; |
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(5) |
the total effective dose equivalent
when required by Rule .1605 of this Section; and |
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(6) |
the total of the deep-dose
equivalent and the committed dose to the organ receiving the highest total dose. |
|
(b) |
The licensee or
registrant shall make entries of the records specified in Paragraph (a) of this Rule at
least annually.
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(c) |
The licensee or
registrant shall maintain the records specified in Paragraph (a) of this Rule on the
agency form for recording occupational radiation doses, in accordance with the
instructions provided with the form, or in clear legible records containing all the
information required by the agency form for recording occupational radiation doses.
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(d) |
Assessments of dose
equivalent and records made using units in effect before the licensee's or registrant's
adoption of the rules in this Section need not be changed.
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(e) |
The records required
under this Rule may be protected from public disclosure because of their personal privacy
nature; however, the limitations in this Paragraph are subject to, and do not omit federal
and state laws that may require disclosure.
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(f) |
The licensee or
registrant shall maintain the records of dose to an embryo/fetus with the records of the
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.
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(g) |
The licensee or
registrant shall retain each required form or record until the agency terminates each
pertinent license or registration requiring the record. |
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Other issues which need to be discussed/provided during
license application are (1) providing the agency with a sample declaration form, (2)
providing a listing of topics and/or publications which will be made available to the
worker when either considering declaration of pregnancy or having declared her pregnancy.
When is an employee
"pregnant?"
An employee is "pregnant" from a radiation
protection standpoint only AFTER she has VOLUNTARILY
declared in writing that she is pregnant and has given her estimated date of
conception. Until that declaration has been given to the licensee (usually the RSO),
the employee is not "pregnant."
It is not within the purview of the licensee (from a
radiation protection standpoint) to require a pregnant worker to declare her
pregnancy. The voluntary component of the declaration MUST be
adhered to in this matter. The Supreme Court has ruled that it is a woman's choice
as to whether her economic or maternal role is of greater importance to her.
Therefore, the licensee cannot make that decision for the woman.
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Can a woman "undeclare"
her pregnancy?
Yes, the declaration can be retracted at ANY TIME
and/or for ANY REASON (see definition above)
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If a woman "undeclares" her
pregnancy and after a time "re-declares" her
pregnancy, how will a licensee demonstrate compliance with the dose limits in Rule .1610?
The answer is contained in Paragraph (d) of Rule .1610:
|
(d) |
If the dose equivalent to the
embryo/fetus is found to have exceeded 0.45 rem (4.5 mSv) by the time the woman declares
the pregnancy to the licensee or registrant, the licensee or registrant shall be deemed to
be in compliance with Paragraph (a) of this Rule if the additional dose the the
embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy. |
Therefore, the licensee shall review all of the woman's
dosimetry records from the monitoring period in which the estimated date of conception
lies and proceed with documenting and demonstrating compliance with Rule .1610
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What topics/issues MUST
be present in an application for the agency to accept the licensee's proposed fetal dose
policy?
At a minimum, the licensee should address the following
regulations and areas within their policy:
|
1. |
Definition of a declared pregnant worker; |
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2. |
Dose restrictions in Rule .1610; |
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3. |
Record keeping requirements specified in
.1640; |
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4. |
Sample form for declaration of pregnancy; |
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5. |
ALARA considerations for keeping the dose to
the embryo/fetus as low as possible; |
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6. |
Method(s) for determining dose to the
embryo/fetus; and |
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7. |
Frequency of dosimetry records review by the
RSO to ensure compliance |
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