| United States Department
of Agriculture
Office of Human Resources Management - Safety and Health Management Division Radiation Safety Staff
Technical Bulletin |
| Radiation Safety Considerations
for the
Declared Pregnant Woman |
| Background |
| As part of its radioactive materials
license, the U.S. Department of Agriculture (USDA) has committed to a safe
environment for all individuals working with radioactive materials or x-ray
producing equipment.
The Nuclear Regulatory Commission's (NRC) Standards for Protection Against Radiation (10 CFR Part 20) require that the dose 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). This dose is ten times lower than the occupational dose allowed for a radiation worker. This document describes how to implement a program that satisfies this safety requirement. |
|
In This Document |
| This document covers the following topics: |
| Topic | See Page | |
| What is a Declared Pregnant Woman? | 2 | |
| USDA Program | 2 | |
| Frequently Asked Questions | 4 | |
| How to Officially Declare a Pregnancy | 8 | |
| Steps to Lower Radiation Dose | 10 | |
| Sources of Additional Information | 11 | |
| Specific References | 12 | |
| Questions Regarding this Bulletin | 13 | |
| Suggested Form Letter for Declaring Pregnancy | 13 |
| Continued on Next Page |
| Approved:
Date: 9/6/96
|
By:
John T. Jensen /S/
|
| What is a Declared Pregnant Woman? |
| Definition | A declared pregnant woman is defined in the NRC regulations as a woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception. |
| Purpose of Declaration | The purpose of making the declaration is to have
the employer take steps to assure that:
- the embryo/fetus is monitored for radiation exposure during the pregnancy; and - the radiation dose is within the regulatory limits. |
|
USDA Program |
| Overview | Regulations require that licensees instruct individuals
working with radioactive materials in radiation protection as appropriate
for the situation. In particular, radiation protection regulations allow
a pregnant woman to decide whether she wants to formally declare her pregnancy
to her employer, thereby taking advantage of the special dose limits provided
to protect the developing embryo/fetus.
Federal safety regulations are gender neutral and it is inappropriate for facility management to arbitrarily place additional restrictions on a woman who appears to be pregnant. By training, women who become pregnant should be aware of the additional safety precautions available to them to assure a low radiation exposure during the gestation period. However, they may be satisfied with their current work situation, and believe that existing precautions and procedures provide an adequate measure of safety during their pregnancy. It is for this reason that the program is voluntary. |
| Training | Instruction concerning prenatal radiation exposure
and its risks to the embryo/fetus will be provided to radiation workers
before they will be allowed to work in a restricted area. Each supervisor
of a female worker who will receive an occupational dose in a restricted
area or a Permit Holder supervising a female Associate User, should also
receive this instruction.
Attendance records, indicating the date of training, and the individuals trained (including their signature) must be maintained by the facility. |
| Continued on Next Page |
| USDA Program, Continued |
| Type of Training | The training should be presented both orally and in written form. Copies of the Frequently Asked Questions and Steps to Lower Radiation Dose (or this entire Technical Bulletin) should be included. Workers should be given the opportunity to ask questions. |
| Duration of Lower Dose Limits | The lower dose limit of 0.5 rem is in effect until
the declared pregnant woman:
- is known to have given birth; - informs the facility that she is no longer pregnant; or - informs the facility that she no longer wants to be considered a declared pregnant woman. Twelve months after the declaration is submitted, the declaration will expire. |
| Additional Consultation | After declaring her pregnancy, the woman should
discuss her work situation with her supervisor, the Permit Holder, the
Location Radiation Protection Officer (LRPO), or other management representative.
The purpose of this consultation is to review past radiation exposures
in the facility, determine the type of changes in work practices, if any,
that are to be made, etc.
Any agreed to changes, or an acknowledgment that no changes are necessary, should be written and signed by all parties. |
| Facility Management Responsibilities | Each USDA facility should review this guidance and
determine how the information will be incorporated into their personnel
management system.
Typically, these declarations are placed in the individual's official personnel file, along with a signed statement from the declared pregnant woman that she has received additional training (such as a review of the Frequently Asked Questions) and consultation regarding her work situation. The LRPO, Permit Holder, supervisor, personnel officer, or other appropriate individual should also sign any other consulting or training documentation. |
| Note: The Frequently Asked Questions, How to Officially Declare a Pregnancy, Steps to Lower Radiation Dose and the Form Letter that follow are taken directly from the NRC's regulatory guide on Instruction Concerning Prenatal Radiation Exposure. | |
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| Frequently Asked Questions |
| 1. If I become pregnant, am I required to inform my employer of my pregnancy? |
| No. It is your choice whether to declare your pregnancy to your employer. If you choose to declare your pregnancy, a lower radiation dose limit will apply to you. If you choose not to declare your pregnancy, you will continue to be subject to the same radiation dose limits that apply to nonpregnant workers even if you are visibly pregnant. |
| 2. If I inform my employer in writing of my pregnancy, what happens? |
| The amount of radiation that you will be allowed to receive will decrease because there is a lower dose limit for the embryo/fetus of female workers who have formally declared their pregnancy in writing. Ordinarily, the radiation dose limit for a worker is 5 rems (50 millisieverts) in a year. But if you declare in writing that you are pregnant, the dose to the embryo/fetus is generally limited to 0.5 rem (5 millisieverts) during the 9-month pregnancy, which is one-tenth of the dose limit that an adult worker may receive in a year. In addition, licensees must make efforts to avoid substantial variation above a uniform monthly dose rate so that all the dose received does not occur during a particular time of the pregnancy. This may mean that, if you declare your pregnancy, you may not be permitted to perform some of your normal job functions and you may not be able to have emergency response responsibilities. |
| 3. Why do the regulations have a lower dose limit for a woman who has declared her pregnancy than for a normal worker? |
| The purpose of the lower limit is to protect her unborn child. Scientific advisory groups recommend (References 1 and 2) that the dose before birth be limited to about 0.5 rem rather than the 5-rem (50-millisievert) occupational annual dose limit because of the sensitivity of the embryo/fetus to radiation. Possible effects include deficiencies in the child's development, especially the child's neurological development, and an increase in the likelihood of cancer. |
| 4. What effects on development can be caused by radiation exposure? |
| The effects of large doses of radiation
on human development are quite evident and easily measurable, whereas at
low doses the effects are not evident or measurable and therefore must
be inferred.
For example, studies of the effects
of radiation on animals and humans demonstrate clearly and conclusively
that large doses of radiation - such as 100 rems (1 sievert) - cause serious
developmental defects in many of the body's organs when the radiation is
delivered during the period of rapid organ development (References 2, 3,
4, and 5).
The developing human brain has been shown to be especially sensitive to radiation. Mental retardation has been observed in the survivors of the atomic bombings in Japan exposed in utero during sensitive periods. |
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| Frequently Asked Questions, Continued |
| 4. What effects on development
can be caused by radiation exposure?
(Continued) |
| Additionally, some other groups exposed
to radiation in utero have shown lower than average intelligence
scores and poor performance in school (Reference 4).
The sensitivity of the brain undoubtedly reflects its structural complexity and its long developmental period (and hence long sensitive period). The most sensitive period is during about the 8th to 15th weeks of gestation followed by a substantially less sensitive period for the two months after the 15th week (Reference 4). There is no known effect on the child's developing brain during the first two months of pregnancy or the last three months of pregnancy (Reference 4). No developmental effects caused by radiation have been observed in human groups at doses at or below the 5-rem (50-millisievert) occupational dose limit. Scientists are uncertain whether there are developmental effects at doses below 5 rems (50 millisieverts). It may be that the effects are present but are too mild to measure because of the normal variability from one person to the next and because the tools to measure the effects are not sensitive enough. Or, it may be that there is some threshold dose below which there are no developmental effects whatsoever. In view of the possibility of developmental effects, even if very mild, at doses below 5 rems (50 millisieverts), scientific advisory groups consider it prudent to limit the dose to the embryo/fetus to 0.5 rem (5 millisieverts) (References 1 and 2). At doses greater than 5 rems (50 millisieverts), such as might be received during an accident or during emergency response activities, the possibility of developmental effects increases. |
| 5. How much will the likelihood of cancer be increased? |
| Radiation exposure has been found
to increase the likelihood of cancer in many studies of adult human and
animal groups. At doses below the occupational dose limit, an increase
in cancer incidence has not been proven, but is presumed to exist even
if it is too small to be measured. The question here is whether the embryo/fetus
is more sensitive to radiation than an adult.
While the evidence for increased sensitivity of the embryo/fetus to cancer induction from radiation exposure is inconclusive, it is prudent to assume that there is some increased sensitivity. Scientific advisory groups assume that radiation exposure before birth may be 2 or 3 times more likely to cause cancer over a person's lifetime than the same amount of radiation received as an adult (Reference 1). If this is true, there would be 1 radiation-induced cancer death in 200 people exposed in utero at the occupational dose limit of 5 rems (50 millisieverts) (Reference 1). Scientific advisory groups have considered this risk to be too high and have thus recommended that the radiation dose to the embryo/fetus be limited to a maximum of 0.5 rem (5 millisieverts). At that dose, there would be 1 radiation-induced cancer death per 2000 people. This would be in addition to the 400 cancer deaths from all causes that one would normally expect in a group of 2000 people. |
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| Frequently Asked Questions, Continued |
| 6. How does the risk to the embryo/fetus from occupational radiation exposure compare to other avoidable risks? |
| The risk to the embryo/fetus from
0.5 rem or even 5 rems of radiation exposure is relatively small compared
to some other avoidable risks.
Of particular concern is excessive
consumption of alcohol during pregnancy. The U.S. Public Health Service
has concluded that heavy alcohol consumption during pregnancy (three drinks
per day and above) is the leading known cause of mental retardation (Reference
6). Children whose mothers drank heavily during pregnancy may exhibit developmental
problems such as hyperactivity, distractibility, short attention spans,
language difficulties, and delayed maturation, even when their intelligence
is normal.
In studies tracking the development
of children born to light or moderate drinkers, researchers have also correlated
their mothers' drinking patterns during pregnancy with low birth weight,
decreased attention spans, delayed reaction times, and lower IQ scores
at age four years. Youngsters whose mothers averaged three drinks per day
during pregnancy were likely to have IQs averaging five points lower than
normal.
Cigarette smoking may also harm the
unborn (Reference 6). There is a direct correlation between the amount
of smoking during pregnancy and the frequency of spontaneous abortion and
fetal death. Children of mothers who smoke while pregnant are more likely
to have impaired intellectual and physical growth. Maternal smoking has
also been associated with such behavioral problems in offspring as lack
of self-control, irritability, hyperactivity, and disinterest. Long-term
studies indicate that these children perform less well than matched youngsters
of nonsmokers on tests of cognitive, psychomotor, language, and general
academic functioning.
Alcohol and smoking are only examples
of other risks in pregnancy. Many other toxic agents and drugs also present
risk. In addition, many factors that cannot be controlled present risk.
There is an increased risk in pregnancy with increasing maternal age. Maternal
disease may be an important risk factor. Malnutrition, toxemia, and congenital
rubella may be associated with birth defects. Maternal diabetes and high
blood pressure have been associated with problems in the newborn. In addition,
many birth defects and developmental problems occur without an obvious
cause and without any obvious risk factors. For example, viruses that we
may not even be aware of can cause defects, and defects can arise from
spontaneous random errors in cell reproduction. But these are things that
we can't do anything about.
In summary, you are advised to keep radiation exposure of your unborn child below 0.5 rem, but you should also remember that alcohol consumption, cigarette smoking, and the use of other drugs can do a great deal of harm. |
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| Frequently Asked Questions, Continued |
| 7. What if I decide that I do not want any radiation exposure at all during my pregnancy? |
| You may ask your employer for a job that does not involve any exposure to occupational radiation at all, but your employer may not have such a position or may not be willing to provide you with a job involving no radiation exposure. Even if you receive no occupational exposure at all, you will receive a dose typically about 0.3 rem (3 millisieverts) from unavoidable natural background radiation (Reference 7). |
| 8. What effect will formally declaring my pregnancy have on my job status? |
| Only your employer can tell you what
effect a declaration of pregnancy will have on your job status. As part
of your radiation safety training, your employer should tell you its policies
with respect to the job status of declared pregnant women. In addition,
we recommend that, before you declare your pregnancy, you talk to your
employer and ask what a declaration of pregnancy would mean specifically
for you and your job status. However, if you do not declare your pregnancy,
the lower exposure limit of 0.5 rem (5 millisieverts) does not apply.
It is most likely that your employer
will tell you that you can continue to perform your job with no changes
and still meet the NRC's limit for exposure to declared pregnant women.
No USDA employees have received, in nine months, occupational radiation
doses that are above the 0.5-rem (5-millisievert) limit for a declared
pregnant woman.
If the dose you currently receive is
above the 0.5-rem (5-millisievert) dose allowed for a declared pregnant
woman, it is quite likely that your employer can and will make a reasonable
accommodation that will allow you to continue performing your current job,
for example, by having another qualified employee perform a small part
of the job that accounts for much of the radiation exposure.
On the other hand, it is possible,
although not common, that your employer will conclude that there is no
reasonable accommodation that can be made without undue hardship that would
allow you to do your job and remain within the dose limits for a declared
pregnant woman. In these few instances, your employer may conclude that
you can no longer be permitted to do your current job, that you must be
removed from your job, and that there is no other job available for someone
with your training and job skills.
If your employer concludes that you must be removed from your current job in order to comply with the lower dose limits for declared pregnant women, you may be concerned about what will happen to you and your job. The answer to that depends on your particular situation. That is why you should talk to your employer about your particular situation. In addition, telephone numbers that may be useful for obtaining information are listed in the Sources of Additional Information. |
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| How to Officially Declare a Pregnancy |
| 1. What information must I provide in my declaration of pregnancy? |
| You must provide your name, a declaration that you are pregnant, the estimated date of conception (only the month and year need be given), and the date that you give the letter to your employer. A sample form letter that you can use is included at the end of this bulletin. You may use that letter or write your own letter. |
| 2. To declare my pregnancy, do I have to have documented medical proof that I am pregnant? |
| No. No proof is necessary. |
| 3. Can I tell my employer orally rather than in writing that I am pregnant? |
| No, the declaration must be in writing. As far as the regulations are concerned, an oral declaration or statement is the same as not telling your employer that you are pregnant. |
| 4. If I have not declared my pregnancy in writing, but my employer notices that I am pregnant, do the lower dose limits apply? |
| No. The lower dose limits for pregnant women apply only if you have declared your pregnancy in writing. The choice of whether to declare your pregnancy and thereby work under the lower dose limits is your choice, not your employer's. Your employer may not remove you from a specific job because you appear pregnant. |
| 5. If I am planning to become pregnant but am not yet pregnant, and I inform my employer of that in writing, do the lower dose limits apply? |
| No. The lower limits apply only if you declare that you are already pregnant. |
| 6. What if I have a miscarriage or find out I am not pregnant? |
| If you have declared your pregnancy
in writing, you should promptly inform your employer that you are no longer
pregnant. The regulations do not require that the revocation of a declaration
be in writing, but we recommend that you revoke the declaration in writing
to avoid confusion. Also, your employer may insist upon a written revocation
for its own protection. If you have not declared your pregnancy, there
is no need to inform your employer of your new, nonpregnant status.
If you have a miscarriage and become pregnant again before you have revoked your original declaration of pregnancy, you should submit a new declaration of pregnancy because the date of conception has changed. |
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| How to Officially Declare a Pregnancy, Continued |
| 7. How long is the lower dose limit in effect? |
| The dose to the embryo/fetus must
be limited until:
(1) your employer knows you have given birth, (2) you inform your employer that you are no longer pregnant, or (3) you inform your employer that you no longer wish to be considered pregnant. |
| 8. If I have declared my pregnancy in writing, can I revoke my declaration of pregnancy even if I am still pregnant? |
| Yes, you may. The choice is entirely yours. If you revoke your declaration of pregnancy, the lower dose limits no longer apply. |
| 9. What if I work under contract at the licensed facility and my employer is not the licensee? |
| The regulations state that you should formally declare your pregnancy to your employer in writing. You can ask your employer to give a copy of your declaration to the licensee, or you may give a copy of your written declaration directly to the licensee. |
| 10. Can I tell my employer I am pregnant when I know I am not in order to work under the lower dose limits? |
| The purpose of the NRC regulations is to allow a pregnant woman to choose a heightened level of protection from radiation exposure for the embryo/fetus during her pregnancy. That purpose would not be served by intentionally declaring yourself to be a pregnant woman when you know you are not pregnant. There are no NRC regulatory requirements specifically addressing the actions your employer might take if you provide a false declaration. However, nothing in NRC regulations would prevent your employer from taking action against you for deliberately lying. |
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| Steps to Lower Radiation Dose |
| Your employer should already have
explained how to keep radiation doses low as part of the instructions that
are given to all workers. However, you should ask your supervisor or the
LRPO whether any additional steps can be taken.
The general principles for maintaining exposure to radiation as low as reasonably achievable are summarized below. You should already be applying these principles to your job, but now is a good time to review them. |
| External Radiation Exposure: External radiation is radiation you receive from radiation sources or radioactive materials that are outside your body. The basic principles for reducing external radiation exposure are time, distance, and shielding - decrease your time near radiation sources, increase your distance from radiation sources, and increase the shielding between yourself and the radiation source. You should work quickly and efficiently in a radiation area so that you are not exposed to the radiation any longer than necessary. As the distance is increased from the source of radiation, the dose decreases. When possible, you should work behind shielding. The shielding will absorb some of the radiation, thus reducing the amount that reaches you. |
| Internal Radiation Exposure:
Internal radiation is radiation you receive from radioactive materials
that have gotten into your body, generally entering with the air you breathe,
the food you eat, or the water you drink. Your employer will have specific
procedures to minimize internal radiation exposure. Those procedures probably
incorporate the following general precautions that should be taken when
you are working with radioactive materials that are not encapsulated:
1. Wear lab coats or other protective clothing if there is a possibility of spills. 2. Use gloves while handling unencapsulated radioactive materials. 3. Wash hands after working with unencapsulated radioactive materials. 4. Do not eat, drink, smoke, or apply cosmetics in areas with unencapsulated radioactive material. 5. Do not pipette radioactive solutions by mouth. |
| These basic principles should be incorporated into the specific methods and procedures for doing your individual work. Your employer should have trained you in those specific rules and procedures. If you become pregnant, it is a good time to review the training materials on the methods and procedures that you were provided in your training. You can also talk to your supervisor about getting refresher training on how to keep radiation doses as low as reasonably achievable. |
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| Sources of Additional Information |
| The USDA's Radiation Safety Handbook contains specific information regarding the types and amounts of radioactive materials and radiation sources used within the Department. The overall Radiation Safety Program is also described. |
| You can find additional information on the risks of radiation in NRC's Regulatory Guide 8.29, "Instruction Concerning Risks from Occupational Radiation Exposure." |
| You can also telephone the NRC Regional
Offices at the following numbers:
Region I (800) 432-1156; Region II (800) 577-8510; Region III (800) 522-3025; and Region IV (800) 952-9677.
These regions are described on NRC
Form-3 "Notice to Employees", which should be posted at your workplace.
Legal questions should be directed to the Regional Counsel, and technical questions should be directed to the Division of Radiation Safety and Safeguards. |
| If you believe you have been discriminated
against, you should contact the U.S. Equal Employment Opportunity Commission
(EEOC), 1801 L Street NW, Washington, DC 20507, or an EEOC Field Office
by calling (800) 669-4000 or (800) 669-EEOC.
For individuals with hearing impairments, the EEOC's TDD number is (800) 800-3302. |
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| Specific References |
| 1. Limitation of Exposure to Ionizing Radiation, Report No. 116, National Council on Radiological Protection and Measurements, Bethesda, MD, 1993. [The National Council on Radiological Protection and Measurements (NCRP) is a nonprofit corporation chartered by Congress in 1964 to collect information and make recommendations on protection against radiation. This publication, on pages 37-39, summarizes the conclusions of the NCRP with respect to protection of the human embryo/fetus against radiation. This publication should be available through most good public library systems and most good university libraries. Your employer may also have a copy.] |
| 2. 1990 Recommendations of the International Commission on Radiological Protection, Ann. ICRP 21: No. 1-3, Pergamon Press, 1991. [This publication, on pages 146-149, summarizes the conclusions of the ICRP on the effects of radiation on the human embryo/fetus.] |
| 3. Health Effects of Exposure to Low Levels of Ionizing Radiation (BEIR V), Committee on the Biological Effects of Ionizing Radiation, National Research Council, National Academy Press, Washington, DC, 1990. |
| 4. United Nations Scientific Committee on the Effects of Atomic Radiation, Sources and Effects of Ionizing Radiation, United Nations, New York, 1993. |
| 5. Considerations Regarding the Unintended Radiation Exposure of the Embryo, Fetus, or Nursing Child, NCRP Commentary No. 9, National Council on Radiation Protection and Measurements, Bethesda, MD, 1994. |
| 6. Alcohol, Tobacco, and Other Drugs May Harm the Unborn, U.S. Department of Health and Human Services, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, DHHS Publication No. (ADM)92-1711, Rockville, Maryland, 1990. |
| 7. Exposure of the Population in the United States and Canada from Natural Background Radiation, Report No. 94, National Council on Radiological Protection and Measurements, Bethesda, MD, 1987. |
| 8. Instruction Concerning Prenatal Radiation Exposure, U.S. Nuclear Regulatory Commission Regulatory Guide 8.13, December, 1987. |
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| Questions Regarding this Bulletin |
| If there are any questions regarding
the USDA radioactive waste management program, contact:
USDA Radiation Safety Staff
Phone: (301) 734-4945
|
|
|
Form Letter For Declaring Pregnancy |
| This form letter is provided for your convenience. To make your declaration of pregnancy, you may fill in the blanks in this form letter and give it to your employer or you may write your own letter. |
Declaration Of Pregnancy
To:
(Name of the facility LRPO, your supervisor or other
employer representative)
I am declaring that I am pregnant. I believe I became pregnant in __________,
(only the month and year need be provided).
I understand that my occupational radiation dose
during my entire pregnancy will not be allowed to exceed 0.5 rem (5 millisieverts)
(unless that dose has already been exceeded between the time of conception
and submitting this letter). I also understand that meeting the lower dose
limit may require a change in job or job responsibilities during my pregnancy.
If I find out that I am not pregnant, or if my pregnancy
is terminated, I will promptly inform you in writing that my pregnancy
has ended. (This promise to inform your employer in writing when your pregnancy
has ended is optional. The sentence may be crossed out if you wish.)
(Your signature)
(Your name printed)
(Date)