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{{#Wiki_filter:...! ..... Q ....M 7r'March 1975 U.S. NUCLEAR REGULATORY  
{{#Wiki_filter:... ! ..... Q....
COMMISSION
                                                                                                                                                                                        M
RE Q U LAT Y GWU DE OFFICE OF STANDARDS  
                                                                                                                                                                                        7r'
DEVELOPMENT
                    U.S. NUCLEAR REGULATORY COMMISSION                                                                                                                       March 1975 RE Q ULAT                                                                          Y GWU DE
REGULATORY  
                    OFFICE OF STANDARDS DEVELOPMENT
GUIDE 8.13 INSTRUCTION  
                                                                                        REGULATORY GUIDE 8.13 INSTRUCTION CONCERNING PRENATAL RADIATION EXPOSURE
CONCERNING  
PRENATAL RADIATION  
EXPOSURE  


==A. INTRODUCTION==
==A. INTRODUCTION==
Section 19.12 of 10 CFR Part 19 states that all individuals working in or frequenting any portion of a restricted area must be instructed in the health pro-tection problcms associated with exposure to radioactive materials or radiation.
after conception, when a womaii may not be aware that she is pregnant, the National Council on Radiation Section 19.12 of 10 CFR Part 19 states that all                               Protection and Measurements (NCRP) recommended in individuals working in or frequenting any portion of a                                 its Report No. 39 that special precautions be taken to restricted area must be instructed in the health pro-                                 limit exposure when an occupationally expo'ed woman tection problcms associated with exposure to radioactive                               could be pregnant.


This guide describes the instruc-tion that should be provided concerning biological risks to embryos or fetuses resulting from prenatal exposure.
materials or radiation. This guide describes the instruc- tion that should be provided concerning biological risks                                                  
 
==C. REGULATORY POSITION==
to embryos or fetuses resulting from prenatal exposure.
 
Instruction to workers performed under § 19.12 should be given prior to assignment to work in a


==B. DISCUSSION==
==B. DISCUSSION==
Since the Law of Bergonie and Tribondeau was published in 19061 it has been known that the sensitiv-ity of cells to radiation damage is related to their reproductive activity and inversely related to their degree of differentiation.
restricted area. In providing instruction about health protection problems associated with radiation exposure, Since the Law of Bergonie and Tribondeau was                                   female workers and those who may supervise or work published in 19061 it has been known that the sensitiv-                                 with them should be given specific instruction about ity of cells to radiation damage is related to their                                   prenatal exposure risks to the developing embryo and reproductive activity and inversely related to their                                   fetus.


It follows that children could W .,," be expected to be more radiosensitive than adults, fetuses more radiosensitive than children, and embryos even more radiosensitive.
degree of differentiation. It follows that children could W.,,"         be expected to be more radiosensitive than adults,                                             The instruction should ensure that the employees fetuses more radiosensitive than children, and embryos                                 understand:
                    even more radiosensitive.


This principle has long been a factor in the development of radiation exposure standards.
1. That the NCRP has recommended holding This principle has long been a factor in the                                 prenatal occupational exposure to 0.5 rem or less during development of radiation exposure standards. Section                                  the entire period of gestation; and
                    20.104 of 10 CFR Part 20 places different limits on minors than on adult workers. Specifically, it limits                                          2.    The reasons for this recommendation.


Section 20.104 of 10 CFR Part 20 places different limits on minors than on adult workers. Specifically, it limits anyone under the age of 18 to exposures not exceeding 10% of the limits for adult workers.A special situation arises when an occupationally , exposed woman is pregnant.
anyone under the age of 18 to exposures not exceeding
                    10% of the limits for adult workers.                                                           The instruction should include the information provided in the Appendix to this guide. It should be A special situation arises when an occupationally                             presented to the employee, her supervisors, and her
,                   exposed woman is pregnant. Exposure of the abdomen                                    co-workers both orally and in written for


Exposure of the abdomen: of such a worker to penetrating radiation from either external or internal sources would also involve exposure of the embtyo or fetus. Because a number of studies have indicated that the embryo or fetus, is more sensitive dthn an adult, particularly during the first three months Corjttes Rendus des Seances de I'Aeademie des Sciences.
====m. Each person====
:                   of such a worker to penetrating radiation from either                                 should be given an opportunity to ask questions, and external or internal sources would also involve exposure                               each person should be asked to acknowledge in writing of the embtyo or fetus. Because a number of studies                                   that the instruction has been received.


VoL 143, pp. 983-985, 1906.after conception, when a womaii may not be aware that she is pregnant, the National Council on Radiation Protection and Measurements (NCRP) recommended in its Report No. 39 that special precautions be taken to limit exposure when an occupationally expo'ed woman could be pregnant.C. REGULATORY
have indicated that the embryo or fetus, is more sensitive dthn an adult, particularly during the first three months                                                       
POSITION Instruction to workers performed under § 19.12 should be given prior to assignment to work in a restricted area. In providing instruction about health protection problems associated with radiation exposure, female workers and those who may supervise or work with them should be given specific instruction about prenatal exposure risks to the developing embryo and fetus.The instruction should ensure that the employees understand:
1. That the NCRP has recommended holding prenatal occupational exposure to 0.5 rem or less during the entire period of gestation;
and 2. The reasons for this recommendation.
 
The instruction should include the information provided in the Appendix to this guide. It should be presented to the employee, her supervisors, and her co-workers both orally and in written form. Each person should be given an opportunity to ask questions, and each person should be asked to acknowledge in writing that the instruction has been received.


==D. IMPLEMENTATION==
==D. IMPLEMENTATION==
The purpose of this section is to provide informa-don to licensees regarding the use of this guid
Corjttes Rendus des Seances de I'Aeademie des Sciences. VoL                                  The purpose of this section is to provide informa-
 
                      143, pp. 983-985, 1906.                                                              don to licensees regarding the use of this guide.
====e. uSNRC REGULATORY ====
GUIDES Comments should be Sent to the Seetelarv oft he Commissiaon.
 
U S Nuttlest Aegelatony Catonrnition.
 
WashingIton.
 
VC. 20M.. Attention locketing ean Rflasototy Guides &to issued to desctibo and myake available to the oub) c 5ef.. Sectio
 
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to the MAC staff of itmplemtenting Wo.Ct t iC parts of the Caommhl,acoon, .#9tittions.


to dtnefiteolt teCh.nose used by tif. rtaff in theh guidaes sansuediolthievoollaviglo Wod divisaons.
uSNRC REGULATORY GUIDES                                          Comments should be Sent to the Seetelarv oft he Commissiaon. U S Nuttlest Aegelatony Catonrnition. WashingIton. VC. 20M.. Attention        locketing ean Rflasototy Guides &to issued to desctibo and myakeavailable        t to the oub) c      5ef..    Section.


euroi soxsocf~c problems of ocislootetd accidents.
oIttehade &rceptebt. to the MAC staff of itmplemtenting Wo.CtiC parts of the Caommhl,acoon,    .#9tittions. to dtnefiteoltteCh.nose used by tif. rtaff in            theh guidaessansuediolthievoollaviglo      Wod divisaons.


or to provide guitdance ittý egol Coons Ae~viso"y Guide* era ..ot substitutes to, *.q..tht-onC.
euroi soxsocf~c problems of ocislootetd accidents. or to provide guitdance ittýegol Coons Ae~viso"y Guide* era ..ot substitutes to, *.q..tht-onC. and COtv1-6til.t          I                                      G. P,odoicts Wttt them, Is not ,acquired Mehd          o ou.n ittfttot            h~ c u O          2. Research an Toll Roesor*"            I Transportation tthe guides rovtitbe occeotabte It they ptoodo a bros, ilat the foondinis rosti ttle to  3 FUG128611od  Meeloatt Vlcod4.0        11.Oecupat~ooa1 "*S~til shot uisi,&we a# lon~tinuance of a petnit or h~eiposby the Cammistsoon                  4                    o  ~i            1 Antitrust Ae,..i C.              Commtittotn and sugge'stect'o for ttttpvereuthsnt t these 5.u'dwsat. encouteogtd Sit40l fit"@. end tedtvlls illo be fewined as sootoop.aft, to accommnodute eorn
                      ~~fts "'d Ito JetlCtnow tot01I'oreton of eleeenence Hooee'.e


and COtv1-6til.t I G. P,odoicts Wttt them, Is not ,acquired Mehd o ou.n ittfttot h~ c u O 2. Research an Toll Roesor*" I Transportation tthe guides rovtit be occeotabte It they ptoodo a bros, ilat the foondinis rosti ttle to 3 FUG128611od Meeloatt Vlcod4.0 11. Oecupat~ooa1
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"*S~til shot uisi,&we a# lon~tinuance of a petnit or h~eipos by the Cammistsoon
                                                                                                            9 Moaterials  and PtessiPlotaee,,on  111.Genetal Copies Of Published girdhes mew be obtained by woollen *equest indicatin~g the l
4 1 o ~i Antitrust Ae,..i Commtittotn and sugge'stect'o for ttttpvereuthsnt t these 5.u'dws a
                    tltri outdoe. ttece-ied viilithS.n400tov      months Altm, t6 isuanarce. 0d1 be coer      divisonsO devs,,., to the U S Nuclear Pogulostory Commsottton. Washington. D C
                          tl.,a~y~saut.teirelogot.n; the noeadto, ust&..I, t",soon                            20W. Alfttent11 Oeiftfor.Office ol SteAdordo Developmen~t ENCLOSURE I


====t. encouteogtd ====
Except In those cases in which the licensee chooses        working in or frequenting any portion of a restricted to propose an alternative method for complying with the          area, and -those who may supervise or work with such portion of the Commission's regulations previously                employees, concerning the health protection problems specified, the methods described herein should be used            associated with prenatal radiation exposure.
9 Moaterials and Ptessi Plotaee,,on
111. Genetal Sit 40l fit"@. end tedtvlls illo be fewined as sootoop.aft, to accommnodute eorn~~fts "'d Ito JetlCt now tot01I'oreton of eleeenence Hooee'.er.


commentt an Copies Of Published girdhes mew be obtained by woollen *equest indicatin~g the tltri outdoe. ttece-ied viilithS.n l 400tov months Altm, t6 isuanarce.
after September 1, 1975, to instruct female employees APPENDIX TO REGULATORY GUIDE 8.13 POSSIBLE HEALTH RISKS TO CHILDREN OF WOMEN
                                WHO ARE EXPOSED TO RADIATION DURING PREGNANCY
    .Some recent studies have shown that the risk of              restricted area of the health protection problems asso- leukemia and other cancers in children increases if the          ciated with radiation exposure. This instruction would in mother Is exposed to a significant amount of radiation          many cases include information on the possible risks to during pregnancy. According to a report by the                  unborn babies. The regulations also state*           that National Academy of Sciences, the incidence of                  licensees should keep radiation exposures as low as leukemia among children under 10 years of age in the            practicable. According to the National Council on United States could rise from 3.7 cases in 10,000                Radiation Protection and Measurements, particular children to 5.6 cases in 10,000 children if the children        efforts should be made to keep the radiation exposure of were exposed to I rem of radiation before birth (a                an embryo or fetus at the very lowest practicable level
"rem" is a measure of radiation). The Academy has also          during the entire period of pregnancy.


0d1 be coer divisonsO
estimated that an equal number of other types of cancers could result from this level of radiation.                    Thus it is the responsibility of your employer to tuthough other scientific studies have shown a much              take all practicable steps to reduce your radiation smaller effect from radiation, the Nuclear Regulatory            exposure. Then it is your responsibility to decide Commission wants women employees of its licensees to              whether the exposure you are receiving is sufficiently be aware of any possible risk so that the women can take          low to protect your unborn child. The advice of your steps they think appropriate to protect their offspring.          employer's health physicist or radiation protection officer should be obtained to determine whether radia- As an employee of a Nuclear Regulatory Commis-              tion levels in your working areas are high enough that a Sion licensee, you may be exposed to more radiation              baby could receive 0.5 rem or more before birth. If so, than the general public. However, the Nuclear Regula-            the alternatives that you might want to consider are:
devs,,., to the U S Nuclear Pogulostory Commsottton.
tory Commission has established a basic exposure limit for all occupationally exposed adults of 1.25 reins per calendar quarter, or 5 reins per year. No clinical evidence            (a) If you are now pregnant or expect to be soon, of harm would be expected in an adult working within              you could decide not to accept or continue assignments these levels for a lifetime. Because the risks of undesir-        in these areas.


Washington.
able effects may be greater for young p)eople, persons under 18.years of age are permitted to be exposed to                    (b) You could reduce your exposure, where only 10 percent of the adu!. occupational limits. (This          possible, by decreasing the amount of time you spend in lower limit is also applied to members of the general              the radiation area, increasing your distance from the public.)                                                          radiation source, and using shielding.


D C tl.,a~y~saut.teirelogot.n;
The scientific organization called the National Council on Radiation Protection and Measurements has                    (c) If you do become pregnant, you could ask your recommended that because unborn babies may be more                employer to reassign you to areas involving less exposure sensitive to radiation than adults, their radiation dose as      to radiation. If this is not possible, you might consider a result of occupational exposure of the mother should            leaving your job. If you decide to take such steps, do so not exceed 0.5 rem. Other scientific groups, including            without delay. The unborn child is most sensitive to the International Commission on Radiation Protection,             radiation during the first three months of your preg.
the noead to, ust &..I, t",soon 20W. Alfttent11 Oeiftfor.Office ol SteAdordo Developmen~t C.ENCLOSURE
I
Except In those cases in which the licensee chooses to propose an alternative method for complying with the portion of the Commission's regulations previously specified, the methods described herein should be used after September
1, 1975, to instruct female employees working in or frequenting any portion of a restricted area, and -those who may supervise or work with such employees, concerning the health protection problems associated with prenatal radiation exposure.APPENDIX TO REGULATORY
GUIDE 8.13 POSSIBLE HEALTH RISKS TO CHILDREN OF WOMEN WHO ARE EXPOSED TO RADIATION
DURING PREGNANCY.Some recent studies have shown that the risk of leukemia and other cancers in children increases if the mother Is exposed to a significant amount of radiation during pregnancy.


According to a report by the National Academy of Sciences, the incidence of leukemia among children under 10 years of age in the United States could rise from 3.7 cases in 10,000 children to 5.6 cases in 10,000 children if the children were exposed to I rem of radiation before birth (a"rem" is a measure of radiation).
have also stressed the need to keep radiation doses to           nancy.
The Academy has also estimated that an equal number of other types of cancers could result from this level of radiation.


tuthough other scientific studies have shown a much smaller effect from radiation, the Nuclear Regulatory Commission wants women employees of its licensees to be aware of any possible risk so that the women can take steps they think appropriate to protect their offspring.
unborn children as low as practicable.


As an employee of a Nuclear Regulatory Commis-Sion licensee, you may be exposed to more radiation than the general public. However, the Nuclear Regula-tory Commission has established a basic exposure limit for all occupationally exposed adults of 1.25 reins per calendar quarter, or 5 reins per year. No clinical evidence of harm would be expected in an adult working within these levels for a lifetime.
(d) You could delay having children until you are All Nuclear Regulatory Cornnii&sion li'ensees are            no longer working in an area where the radiation dose to now required* to inform all Individuals who work in a             your unborn baby could exceed 0.5 rem.


Because the risks of undesir-able effects may be greater for young p)eople, persons under 18.years of age are permitted to be exposed to only 10 percent of the adu!. occupational limits. (This lower limit is also applied to members of the general public.)The scientific organization called the National Council on Radiation Protection and Measurements has recommended that because unborn babies may be more sensitive to radiation than adults, their radiation dose as a result of occupational exposure of the mother should not exceed 0.5 rem. Other scientific groups, including the International Commission on Radiation Protection, have also stressed the need to keep radiation doses to unborn children as low as practicable.
*By Title 10. Part 19 of the Code of Federai Regulations.       "In Title 10, Part 20.


All Nuclear Regulatory Cornnii&sion li'ensees are now required*
8.13-2
to inform all Individuals who work in a*By Title 10. Part 19 of the Code of Federai Regulations.


restricted area of the health protection problems asso-ciated with radiation exposure.
- ------------
                    You may also, of course, choose to:                            0.072 rem per year. The average dose from one chest X-ray is 0.045 rem.


This instruction would in many cases include information on the possible risks to unborn babies. The regulations also state* that licensees should keep radiation exposures as low as practicable.
(e) Continue working in the higher radiation areas, but with full awareness that you are doing so at some                Radiation can also be received from natural sources small increased risk for your unborn child.                    such as rock or brick structures, front consumer pro- ducts such as television and glow-in-the-dark watches, The following facts should be noted to help you make a          and from air travel. The possible annual dose from decision:                                                      working 8 hours a day near a granite wall at the Redcap Stand in Grand Central Station, New York City, is 0.2
                          1. The first three months of pregnancy are the            rem, and the average annual dose in the United States most important, so you should make your decision              from TV, consumer products, and air travel is 0.0026 quickly.                                                      rem.


According to the National Council on Radiation Protection and Measurements, particular efforts should be made to keep the radiation exposure of an embryo or fetus at the very lowest practicable level during the entire period of pregnancy.
2. At the present occupational exposure limit, the             Radiation, like many things, can be harmful. A large actual risk to the unborn baby is small, but experts          dose to the whole body (such as 600 reins in one day)
                    disagree on the exact amount of risk.                         would probably cause death in about 30 days, but such large doses result only from rare accident


Thus it is the responsibility of your employer to take all practicable steps to reduce your radiation exposure.
====s. Control of====
                          3. There is no need to be concerned about sterility      exposure to radiation is based on the assumption that or loss of your ability to bear children. The radiation         any exposure, no matter how small, involves some risk.


Then it is your responsibility to decide whether the exposure you are receiving is sufficiently low to protect your unborn child. The advice of your employer's health physicist or radiation protection officer should be obtained to determine whether radia-tion levels in your working areas are high enough that a baby could receive 0.5 rem or more before birth. If so, the alternatives that you might want to consider are: (a) If you are now pregnant or expect to be soon, you could decide not to accept or continue assignments in these areas.(b) You could reduce your exposure, where possible, by decreasing the amount of time you spend in the radiation area, increasing your distance from the radiation source, and using shielding.(c) If you do become pregnant, you could ask your employer to reassign you to areas involving less exposure to radiation.
dose required to produce such effects is more than 100          The occupational exposure limits are set so low, how- times larger than the Nuclear Regulatory Commission's           ever, that medical evidence gathered over the past 50
                    dose limits for adults.                                        years indicates no clinically observable injuries to indi- viduals due to radiation exposures when the established
                        4. Even if you work in an area where you receive            radiation limits are not exceeded. This was true even for only 0.5 rem per three-month period, in nine months              exposures received under the early occupational ex- you could receive 1.5 reins, which exceeds the full-term        posure limits, which were many times higher than the limit suggested by the NCRP. Therefore, if you d&cide to        present limits. Thus the risk to individuals at the restrict your unborn baby's exposure as recommended            occupational exposure levels is considered to be very by the NCRP, be aware that the 0.5 rem limit applies to        low. However, it is impossible to say that the risk is zero.


If this is not possible, you might consider leaving your job. If you decide to take such steps, do so without delay. The unborn child is most sensitive to radiation during the first three months of your preg.nancy.(d) You could delay having children until you are no longer working in an area where the radiation dose to your unborn baby could exceed 0.5 rem."In Title 10, Part 20.8.13-2
*                  the full nine-month pregnancy.                                 To decrease the risk still further, licensees are expected to keep actual exposures as far below the limits as
-------------
                **      The remainder of this document contains a brief            practicable.
You may also, of course, choose to: (e) Continue working in the higher radiation areas, but with full awareness that you are doing so at some small increased risk for your unborn child.The following facts should be noted to help you make a decision: 1. The first three months of pregnancy are the most important, so you should make your decision quickly.2. At the present occupational exposure limit, the actual risk to the unborn baby is small, but experts disagree on the exact amount of risk.3. There is no need to be concerned about sterility or loss of your ability to bear children.


The radiation dose required to produce such effects is more than 100 times larger than the Nuclear Regulatory Commission's dose limits for adults.4. Even if you work in an area where you receive only 0.5 rem per three-month period, in nine months you could receive 1.5 reins, which exceeds the full-term limit suggested by the NCRP. Therefore, if you d&cide to restrict your unborn baby's exposure as recommended by the NCRP, be aware that the 0.5 rem limit applies to* the full nine-month pregnancy.The remainder of this document contains a brief explanation of radiation and its effects on humans. As you will see, some radiation is present everywhere and the levels of radiation most employees of Nuclear Regulatory Commission licensees receive are not much larger than these natural levels. Because the radiation levels in the facility where you will be working are required by law to be kept quite low, there is not considered to be a significant health risk to individual adult employees.
explanation of radiation and its effects on humans. As you will see, some radiation is present everywhere and               The current exposure limits for people working with the levels of radiation most employees of Nuclear               radiation have been developed and carefully reviewed by Regulatory Commission licensees receive are not much           nationally and internationally recognized groups of larger than these natural levels. Because the radiation         scientists. It must be remembered, however, that these levels in the facility where you will be working are             limits are for adults. Special consideration is appropriate required by law to be kept quite low, there is not             when the person being exposed is, or may be, an considered to be a significant health risk to individual         expectant mother, because the exposure of an unborn adult employees.                                                child may also be involved.


0.072 rem per year. The average dose from one chest X-ray is 0.045 rem.Radiation can also be received from natural sources such as rock or brick structures, front consumer pro-ducts such as television and glow-in-the-dark watches, and from air travel. The possible annual dose from working 8 hours a day near a granite wall at the Redcap Stand in Grand Central Station, New York City, is 0.2 rem, and the average annual dose in the United States from TV, consumer products, and air travel is 0.0026 rem.Radiation, like many things, can be harmful. A large dose to the whole body (such as 600 reins in one day)would probably cause death in about 30 days, but such large doses result only from rare accidents.
Discussion of Radiation The amount of radiation a person receives is called                            Prenatal Irradiation the "dose" and is measured in "reins." The average peron in the United States gets a dose of one rem from              The prediction that an unborn child would be more sensitive to radiation than an adult is supported by natural sources every 12 years. The dose from natural observations for relatively large doses. Large doses radiation is higher in some states, such as Colorado, delivered before birth alter both physical development Wyoming, and South Dakota, primarily because of and behavior in experimentally exposed animals. A
                    cosmic. radiation. There the average person gets one rem report of the National Academy of Sciences states that every 8 years.


Control of exposure to radiation is based on the assumption that any exposure, no matter how small, involves some risk.The occupational exposure limits are set so low, how-ever, that medical evidence gathered over the past 50 years indicates no clinically observable injuries to indi-viduals due to radiation exposures when the established radiation limits are not exceeded.
short-term doses in the range of 10 to 20 reins cause Natural background radiation levels are also much        subtle changes In the nerve cells of unborn and infant higher in certain local areas. A dose of one rem may be          rats. The report also states, however, that no radiation- received in some areas on the beach at Guarapari, Brazil,       induced changes in development have been demon- in only about 9 days, and some people in Kerala, India,       strated to result In experimental animals from doses up get a dose of one rem every 5 months.                            to about I rem per day extended over a large part of the period before birth.


This was true even for exposures received under the early occupational ex-posure limits, which were many times higher than the present limits. Thus the risk to individuals at the occupational exposure levels is considered to be very low. However, it is impossible to say that the risk is zero.To decrease the risk still further, licensees are expected to keep actual exposures as far below the limits as practicable.
Many people receive additional radiation for
    'C              medical reasons. The annual radiation dose averaged over the United States population from diagnostic X.rays is The National Academy of Sciences also noted that doses of 25 to 50 reins to a pregnant human may cause
                                                                              8.13-3


The current exposure limits for people working with radiation have been developed and carefully reviewed by nationally and internationally recognized groups of scientists.
growth disturbances in her offspring. Such doses sub.                                      Bibliography stantially exceed. of course, the maximum permissible Donald G. Pizzarello and Richard L. Witcofski, occupational exposure limits.


It must be remembered, however, that these limits are for adults. Special consideration is appropriate when the person being exposed is, or may be, an expectant mother, because the exposure of an unborn child may also be involved.Prenatal Irradiation The prediction that an unborn child would be more sensitive to radiation than an adult is supported by observations for relatively large doses. Large doses delivered before birth alter both physical development and behavior in experimentally exposed animals. A report of the National Academy of Sciences states that short-term doses in the range of 10 to 20 reins cause subtle changes In the nerve cells of unborn and infant rats. The report also states, however, that no radiation- induced changes in development have been demon-strated to result In experimental animals from doses up to about I rem per day extended over a large part of the period before birth.The National Academy of Sciences also noted that doses of 25 to 50 reins to a pregnant human may cause Discussion of Radiation The amount of radiation a person receives is called the "dose" and is measured in "reins." The average peron in the United States gets a dose of one rem from natural sources every 12 years. The dose from natural radiation is higher in some states, such as Colorado, Wyoming, and South Dakota, primarily because of cosmic. radiation.
Basic Radiation Biology, Philadelphia: Lea and Concern about prenatal exposure (i.e., exposure of a           Febizer. 1967.


There the average person gets one rem every 8 years.Natural background radiation levels are also much higher in certain local areas. A dose of one rem may be received in some areas on the beach at Guarapari, Brazil, in only about 9 days, and some people in Kerala, India, get a dose of one rem every 5 months.Many people receive additional radiation for medical reasons. The annual radiation dose averaged over the United States population from diagnostic X.rays is'C 8.13-3 growth disturbances in her offspring.
child while in its mother's uterus) at the permissible occupational levels is primarily based on the possibility        2. National Academy of Sciences - National Research that cancer (especially leukemia) may develop during the              Council, The Effccts on Populationsof Exposure to first 10 years of the child's life. Several studies have been          Low Levels of Ioni:ing Radiation, Washington, performed to evaluate this risk. One study involved the               D.C., November 1972.


Such doses sub.stantially exceed. of course, the maximum permissible occupational exposure limits.Concern about prenatal exposure (i.e., exposure of a child while in its mother's uterus) at the permissible occupational levels is primarily based on the possibility that cancer (especially leukemia)
followup of 77.000 children exposed to radiation before birth (because of diagnostic abdominal X-rays made for             3.  National Council on Radiation Protection and medical purposes during their mother's pregnancy).                     Measurements. Basic Radiation Protection Criteria, Another stud)y involved the followup of 20.000 such                   NCRP Report No. 39, Washington, D.C., January children. In addition, 1292 children who received                      15, 1971.
may develop during the first 10 years of the child's life. Several studies have been performed to evaluate this risk. One study involved the followup of 77.000 children exposed to radiation before birth (because of diagnostic abdominal X-rays made for medical purposes during their mother's pregnancy).
Another stud)y involved the followup of 20.000 such children.


In addition, 1292 children who received prenatal exposure during the bombing of Hiroshima and Nagasaki were studied. Although contradictory results have been obtained, most of the evidence sugests a relationship between prenatal exposure and an increased risk of childhood cancer.Summary Occupational exposures to radiation arc being kept low. flowever, qualified scientists have recommended that the radiation dose to a pregn,,.nt woman should not exceed 0.5 rem because of possible risks to her unborn child. Since this 0.5 rem is lower than the dose generally permitted to adult workers, women may want to take special actions to avoid receiving higher exposures, just as they might stop smoking during pregnancy or might climb stairs more carefully to reduce possible risks to their unborn children.Bibliography Donald G. Pizzarello and Richard L. Witcofski, Basic Radiation Biology, Philadelphia:
prenatal exposure during the bombing of Hiroshima and            4.  United Nations. Ionizing Radiation: Levels and Nagasaki were studied. Although contradictory results                 Effects, 2 vol., Reports of the United Nations have been obtained, most of the evidence sugests a                   Scientific Committee on the Effects of Atomic relationship between prenatal exposure and an increased               Radiation, Report No. A/8725, United Nations.
Lea and Febizer. 1967.2. National Academy of Sciences -National Research Council, The Effccts on Populations of Exposure to Low Levels of Ioni:ing Radiation, Washington, D.C., November 1972.3. National Council on Radiation Protection and Measurements.


Basic Radiation Protection Criteria, NCRP Report No. 39, Washington, D.C., January 15, 1971.4. United Nations. Ionizing Radiation:
risk of childhood cancer.                                             New York, 1972.
Levels and Effects, 2 vol., Reports of the United Nations Scientific Committee on the Effects of Atomic Radiation, Report No. A/8725, United Nations.New York, 1972.5. US. Atomic Energy Commission, Division of Technical Information, Understanding the Atom Series: Atoms, Nature and Alan The Genetic Effects of Radiation The Natural Radiation Environment Your Body and Radiation UNITED STATES NUCLEAR REGULATORY
COMMISSION
WASHINGTON.


0. C. 20555 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300 POSTAGE AND FEES PAID UPCI?(O STAT(1 NIJCt(AR IREGULATOftV  
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                                                                  5.  US. Atomic Energy Commission, Division of Occupational exposures to radiation arc being kept              Technical Information, Understanding the Atom low. flowever, qualified scientists have recommended                  Series:
'-I 8.13-4}}
that the radiation dose to a pregn,,.nt woman should not exceed 0.5 rem because of possible risks to her unborn                      Atoms, Nature and Alan child. Since this 0.5 rem is lower than the dose generally permitted to adult workers, women may want to take                          The Genetic Effects of Radiation special actions to avoid receiving higher exposures, just as they might stop smoking during pregnancy or might                        The NaturalRadiation Environment climb stairs more carefully to reduce possible risks to their unborn children.                                                      Your Body and Radiation UNITED STATES
NUCLEAR REGULATORY COMMISSION
      WASHINGTON. 0. C. 20555 POSTAGE AND FEES PAID
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Instruction Concerning Prenatal Radiation Exposure
ML13350A220
Person / Time
Issue date: 03/31/1975
From:
NRC/OSD
To:
References
RG-8.013
Download: ML13350A220 (4)


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U.S. NUCLEAR REGULATORY COMMISSION March 1975 RE Q ULAT Y GWU DE

OFFICE OF STANDARDS DEVELOPMENT

REGULATORY GUIDE 8.13 INSTRUCTION CONCERNING PRENATAL RADIATION EXPOSURE

A. INTRODUCTION

after conception, when a womaii may not be aware that she is pregnant, the National Council on Radiation Section 19.12 of 10 CFR Part 19 states that all Protection and Measurements (NCRP) recommended in individuals working in or frequenting any portion of a its Report No. 39 that special precautions be taken to restricted area must be instructed in the health pro- limit exposure when an occupationally expo'ed woman tection problcms associated with exposure to radioactive could be pregnant.

materials or radiation. This guide describes the instruc- tion that should be provided concerning biological risks

C. REGULATORY POSITION

to embryos or fetuses resulting from prenatal exposure.

Instruction to workers performed under § 19.12 should be given prior to assignment to work in a

B. DISCUSSION

restricted area. In providing instruction about health protection problems associated with radiation exposure, Since the Law of Bergonie and Tribondeau was female workers and those who may supervise or work published in 19061 it has been known that the sensitiv- with them should be given specific instruction about ity of cells to radiation damage is related to their prenatal exposure risks to the developing embryo and reproductive activity and inversely related to their fetus.

degree of differentiation. It follows that children could W.,," be expected to be more radiosensitive than adults, The instruction should ensure that the employees fetuses more radiosensitive than children, and embryos understand:

even more radiosensitive.

1. That the NCRP has recommended holding This principle has long been a factor in the prenatal occupational exposure to 0.5 rem or less during development of radiation exposure standards. Section the entire period of gestation; and

20.104 of 10 CFR Part 20 places different limits on minors than on adult workers. Specifically, it limits 2. The reasons for this recommendation.

anyone under the age of 18 to exposures not exceeding

10% of the limits for adult workers. The instruction should include the information provided in the Appendix to this guide. It should be A special situation arises when an occupationally presented to the employee, her supervisors, and her

, exposed woman is pregnant. Exposure of the abdomen co-workers both orally and in written for

m. Each person

of such a worker to penetrating radiation from either should be given an opportunity to ask questions, and external or internal sources would also involve exposure each person should be asked to acknowledge in writing of the embtyo or fetus. Because a number of studies that the instruction has been received.

have indicated that the embryo or fetus, is more sensitive dthn an adult, particularly during the first three months

D. IMPLEMENTATION

Corjttes Rendus des Seances de I'Aeademie des Sciences. VoL The purpose of this section is to provide informa-

143, pp. 983-985, 1906. don to licensees regarding the use of this guide.

uSNRC REGULATORY GUIDES Comments should be Sent to the Seetelarv oft he Commissiaon. U S Nuttlest Aegelatony Catonrnition. WashingIton. VC. 20M.. Attention locketing ean Rflasototy Guides &to issued to desctibo and myakeavailable t to the oub) c 5ef.. Section.

oIttehade &rceptebt. to the MAC staff of itmplemtenting Wo.CtiC parts of the Caommhl,acoon, .#9tittions. to dtnefiteoltteCh.nose used by tif. rtaff in theh guidaessansuediolthievoollaviglo Wod divisaons.

euroi soxsocf~c problems of ocislootetd accidents. or to provide guitdance ittýegol Coons Ae~viso"y Guide* era ..ot substitutes to, *.q..tht-onC. and COtv1-6til.t I G. P,odoicts Wttt them, Is not ,acquired Mehd o ou.n ittfttot h~ c u O 2. Research an Toll Roesor*" I Transportation tthe guides rovtitbe occeotabte It they ptoodo a bros, ilat the foondinis rosti ttle to 3 FUG128611od Meeloatt Vlcod4.0 11.Oecupat~ooa1 "*S~til shot uisi,&we a# lon~tinuance of a petnit or h~eiposby the Cammistsoon 4 o ~i 1 Antitrust Ae,..i C. Commtittotn and sugge'stect'o for ttttpvereuthsnt t these 5.u'dwsat. encouteogtd Sit40l fit"@. end tedtvlls illo be fewined as sootoop.aft, to accommnodute eorn

~~fts "'d Ito JetlCtnow tot01I'oreton of eleeenence Hooee'.e

r. commentt an

9 Moaterials and PtessiPlotaee,,on 111.Genetal Copies Of Published girdhes mew be obtained by woollen *equest indicatin~g the l

tltri outdoe. ttece-ied viilithS.n400tov months Altm, t6 isuanarce. 0d1 be coer divisonsO devs,,., to the U S Nuclear Pogulostory Commsottton. Washington. D C

tl.,a~y~saut.teirelogot.n; the noeadto, ust&..I, t",soon 20W. Alfttent11 Oeiftfor.Office ol SteAdordo Developmen~t ENCLOSURE I

Except In those cases in which the licensee chooses working in or frequenting any portion of a restricted to propose an alternative method for complying with the area, and -those who may supervise or work with such portion of the Commission's regulations previously employees, concerning the health protection problems specified, the methods described herein should be used associated with prenatal radiation exposure.

after September 1, 1975, to instruct female employees APPENDIX TO REGULATORY GUIDE 8.13 POSSIBLE HEALTH RISKS TO CHILDREN OF WOMEN

WHO ARE EXPOSED TO RADIATION DURING PREGNANCY

.Some recent studies have shown that the risk of restricted area of the health protection problems asso- leukemia and other cancers in children increases if the ciated with radiation exposure. This instruction would in mother Is exposed to a significant amount of radiation many cases include information on the possible risks to during pregnancy. According to a report by the unborn babies. The regulations also state* that National Academy of Sciences, the incidence of licensees should keep radiation exposures as low as leukemia among children under 10 years of age in the practicable. According to the National Council on United States could rise from 3.7 cases in 10,000 Radiation Protection and Measurements, particular children to 5.6 cases in 10,000 children if the children efforts should be made to keep the radiation exposure of were exposed to I rem of radiation before birth (a an embryo or fetus at the very lowest practicable level

"rem" is a measure of radiation). The Academy has also during the entire period of pregnancy.

estimated that an equal number of other types of cancers could result from this level of radiation. Thus it is the responsibility of your employer to tuthough other scientific studies have shown a much take all practicable steps to reduce your radiation smaller effect from radiation, the Nuclear Regulatory exposure. Then it is your responsibility to decide Commission wants women employees of its licensees to whether the exposure you are receiving is sufficiently be aware of any possible risk so that the women can take low to protect your unborn child. The advice of your steps they think appropriate to protect their offspring. employer's health physicist or radiation protection officer should be obtained to determine whether radia- As an employee of a Nuclear Regulatory Commis- tion levels in your working areas are high enough that a Sion licensee, you may be exposed to more radiation baby could receive 0.5 rem or more before birth. If so, than the general public. However, the Nuclear Regula- the alternatives that you might want to consider are:

tory Commission has established a basic exposure limit for all occupationally exposed adults of 1.25 reins per calendar quarter, or 5 reins per year. No clinical evidence (a) If you are now pregnant or expect to be soon, of harm would be expected in an adult working within you could decide not to accept or continue assignments these levels for a lifetime. Because the risks of undesir- in these areas.

able effects may be greater for young p)eople, persons under 18.years of age are permitted to be exposed to (b) You could reduce your exposure, where only 10 percent of the adu!. occupational limits. (This possible, by decreasing the amount of time you spend in lower limit is also applied to members of the general the radiation area, increasing your distance from the public.) radiation source, and using shielding.

The scientific organization called the National Council on Radiation Protection and Measurements has (c) If you do become pregnant, you could ask your recommended that because unborn babies may be more employer to reassign you to areas involving less exposure sensitive to radiation than adults, their radiation dose as to radiation. If this is not possible, you might consider a result of occupational exposure of the mother should leaving your job. If you decide to take such steps, do so not exceed 0.5 rem. Other scientific groups, including without delay. The unborn child is most sensitive to the International Commission on Radiation Protection, radiation during the first three months of your preg.

have also stressed the need to keep radiation doses to nancy.

unborn children as low as practicable.

(d) You could delay having children until you are All Nuclear Regulatory Cornnii&sion li'ensees are no longer working in an area where the radiation dose to now required* to inform all Individuals who work in a your unborn baby could exceed 0.5 rem.

  • By Title 10. Part 19 of the Code of Federai Regulations. "In Title 10, Part 20.

8.13-2

- ------------

You may also, of course, choose to: 0.072 rem per year. The average dose from one chest X-ray is 0.045 rem.

(e) Continue working in the higher radiation areas, but with full awareness that you are doing so at some Radiation can also be received from natural sources small increased risk for your unborn child. such as rock or brick structures, front consumer pro- ducts such as television and glow-in-the-dark watches, The following facts should be noted to help you make a and from air travel. The possible annual dose from decision: working 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> a day near a granite wall at the Redcap Stand in Grand Central Station, New York City, is 0.2

1. The first three months of pregnancy are the rem, and the average annual dose in the United States most important, so you should make your decision from TV, consumer products, and air travel is 0.0026 quickly. rem.

2. At the present occupational exposure limit, the Radiation, like many things, can be harmful. A large actual risk to the unborn baby is small, but experts dose to the whole body (such as 600 reins in one day)

disagree on the exact amount of risk. would probably cause death in about 30 days, but such large doses result only from rare accident

s. Control of

3. There is no need to be concerned about sterility exposure to radiation is based on the assumption that or loss of your ability to bear children. The radiation any exposure, no matter how small, involves some risk.

dose required to produce such effects is more than 100 The occupational exposure limits are set so low, how- times larger than the Nuclear Regulatory Commission's ever, that medical evidence gathered over the past 50

dose limits for adults. years indicates no clinically observable injuries to indi- viduals due to radiation exposures when the established

4. Even if you work in an area where you receive radiation limits are not exceeded. This was true even for only 0.5 rem per three-month period, in nine months exposures received under the early occupational ex- you could receive 1.5 reins, which exceeds the full-term posure limits, which were many times higher than the limit suggested by the NCRP. Therefore, if you d&cide to present limits. Thus the risk to individuals at the restrict your unborn baby's exposure as recommended occupational exposure levels is considered to be very by the NCRP, be aware that the 0.5 rem limit applies to low. However, it is impossible to say that the risk is zero.

  • the full nine-month pregnancy. To decrease the risk still further, licensees are expected to keep actual exposures as far below the limits as
    • The remainder of this document contains a brief practicable.

explanation of radiation and its effects on humans. As you will see, some radiation is present everywhere and The current exposure limits for people working with the levels of radiation most employees of Nuclear radiation have been developed and carefully reviewed by Regulatory Commission licensees receive are not much nationally and internationally recognized groups of larger than these natural levels. Because the radiation scientists. It must be remembered, however, that these levels in the facility where you will be working are limits are for adults. Special consideration is appropriate required by law to be kept quite low, there is not when the person being exposed is, or may be, an considered to be a significant health risk to individual expectant mother, because the exposure of an unborn adult employees. child may also be involved.

Discussion of Radiation The amount of radiation a person receives is called Prenatal Irradiation the "dose" and is measured in "reins." The average peron in the United States gets a dose of one rem from The prediction that an unborn child would be more sensitive to radiation than an adult is supported by natural sources every 12 years. The dose from natural observations for relatively large doses. Large doses radiation is higher in some states, such as Colorado, delivered before birth alter both physical development Wyoming, and South Dakota, primarily because of and behavior in experimentally exposed animals. A

cosmic. radiation. There the average person gets one rem report of the National Academy of Sciences states that every 8 years.

short-term doses in the range of 10 to 20 reins cause Natural background radiation levels are also much subtle changes In the nerve cells of unborn and infant higher in certain local areas. A dose of one rem may be rats. The report also states, however, that no radiation- received in some areas on the beach at Guarapari, Brazil, induced changes in development have been demon- in only about 9 days, and some people in Kerala, India, strated to result In experimental animals from doses up get a dose of one rem every 5 months. to about I rem per day extended over a large part of the period before birth.

Many people receive additional radiation for

'C medical reasons. The annual radiation dose averaged over the United States population from diagnostic X.rays is The National Academy of Sciences also noted that doses of 25 to 50 reins to a pregnant human may cause

8.13-3

growth disturbances in her offspring. Such doses sub. Bibliography stantially exceed. of course, the maximum permissible Donald G. Pizzarello and Richard L. Witcofski, occupational exposure limits.

Basic Radiation Biology, Philadelphia: Lea and Concern about prenatal exposure (i.e., exposure of a Febizer. 1967.

child while in its mother's uterus) at the permissible occupational levels is primarily based on the possibility 2. National Academy of Sciences - National Research that cancer (especially leukemia) may develop during the Council, The Effccts on Populationsof Exposure to first 10 years of the child's life. Several studies have been Low Levels of Ioni:ing Radiation, Washington, performed to evaluate this risk. One study involved the D.C., November 1972.

followup of 77.000 children exposed to radiation before birth (because of diagnostic abdominal X-rays made for 3. National Council on Radiation Protection and medical purposes during their mother's pregnancy). Measurements. Basic Radiation Protection Criteria, Another stud)y involved the followup of 20.000 such NCRP Report No. 39, Washington, D.C., January children. In addition, 1292 children who received 15, 1971.

prenatal exposure during the bombing of Hiroshima and 4. United Nations. Ionizing Radiation: Levels and Nagasaki were studied. Although contradictory results Effects, 2 vol., Reports of the United Nations have been obtained, most of the evidence sugests a Scientific Committee on the Effects of Atomic relationship between prenatal exposure and an increased Radiation, Report No. A/8725, United Nations.

risk of childhood cancer. New York, 1972.

Summary

5. US. Atomic Energy Commission, Division of Occupational exposures to radiation arc being kept Technical Information, Understanding the Atom low. flowever, qualified scientists have recommended Series:

that the radiation dose to a pregn,,.nt woman should not exceed 0.5 rem because of possible risks to her unborn Atoms, Nature and Alan child. Since this 0.5 rem is lower than the dose generally permitted to adult workers, women may want to take The Genetic Effects of Radiation special actions to avoid receiving higher exposures, just as they might stop smoking during pregnancy or might The NaturalRadiation Environment climb stairs more carefully to reduce possible risks to their unborn children. Your Body and Radiation UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON. 0. C. 20555 POSTAGE AND FEES PAID

UPCI?(O STAT(1 NIJCt(AR

OFFICIAL BUSINESS IREGULATOftV COMMISSION

PENALTY FOR PRIVATE USE, $300

'-I

8.13-4