Regulatory Guide 8.13

Instruction Concerning Prenatal Radiation Exposure

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Issue date:	06/30/1999
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U.S. NUCLEAR REGULATORY COMMISSION

REGULATORY

Revision 3 June 1999 GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 8.13 (Draft was issued as DG-801 4)

INSTRUCTION CONCERNING PRENATAL RADIATION EXPOSURE

A. INTRODUCTION

The Code of Federal Regulations in 10 CFR Part

19, "Notices, Instructions and Reports to Workers: In spection and Investigations," in Section 19.12, "In structions to Workers," requires instruction in "the health protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed." The in structions must be "commensurate with potential ra diological health protection problems present in the work place."

The Nuclear Regulatory Commission's (NRC's)

regulations on radiation protection are specified in 10

CFR Part 20, "Standards for Protection Against Radi ation"; and 10 CFR 20.1208, "Dose to an Embryo/

Fetus," requires licensees to "ensure that the dose to an embryo/fetus during the entire pregnancy, due to occu pational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv)." Section 20.1208 also re quires licensees to "make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman." A declared pregnant woman is defined in 10 CFR 20.1003 as a woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception.

This regulatory guide is intended to provide infor mation to pregnant women, and other personnel, to help them make decisions regarding radiation exposure dur ing pregnancy. This Regulatory Guide 8.13 supple ments Regulatory Guide 8.29, "Instruction Conceming Risks from Occupational Radiation Exposure" (Ref.

1), which contains a broad discussion of the risks from exposure to ionizing radiation.

Other sections of the NRC's regulations also speci fy requirements for monitoring external and internal occupational dose to a declared pregnant woman. In 10

CFR 20.1502, "Conditions Requiring Individual Mon itoring of External and Internal Occupational Dose," li censees are required to monitor the occupational dose to a declared pregnant woman, using an individual monitoring device, if it is likely that the declared preg nant woman will receive, from external sources, a deep dose equivalent in excess of 0.1 rem (1 mSv). Accord ing to Paragraph (e) of 10 CFR 20.2106, "Records of Individual Monitoring Results," the licensee must maintain records of dose to an embryo/fetus if monitor ing was required, and the records of dose to the embryo/

fetus must be kept with the records of dose to the de clared pregnant woman. The declaration of pregnancy must be kept on file, but may be maintained separately from the dose records. The licensee must retain the re- USNRC REGULATORY GUIDES

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10. General will be acceptable if they provide a basis forthe findings requisite to the issuance orcon tinuance of a permit or license by the Commission.

Single copies of regulatory guides may be obtained free of charge by writing to the Repro This guide was issued after consideration of comments received from the public. Corn- duction and Distribution Services Section, OCIO, U.S. Nuclear Regulatory Commission, mentsandsuggestionsforimprovementsintheseguidesareencouragedatalltimes, and Washington, DC 20555-0001. or by fax to (301)415-2289; or by e-mail to DISTRIBU

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Royal Road, Springfield, VA 22161.

quired form or record until the Commission terminates each pertinent license requiring the record.

The information collections in this regulatory guide are covered by the requirements of 10 CFR Parts

19 or 20, which were approved by the Office of Man agement and Budget, approval numbers 3150-0044 and

3150-0014, respectively. The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

B. DISCUSSION

As discussed in Regulatory Guide 8.29 (Ref. 1),

exposure to any level of radiation is assumed to carry with it a certain amount of risk. In the absence of scien tific certainty regarding the relationship between low dose exposure and health effects, and as a conservative assumption for radiation protection purposes, the scientific community generally assumes that any expo sure to ionizing radiation may cause undesirable bio logical effects and that the likelihood of these effects in creases as the dose increases. At the occupational dose limit for the whole body of 5 rem (50 mSv) per year, the risk is believed to be very low.

The magnitude of risk of childhood cancer follow ing in utero exposure is uncertain in that both negative and positive studies have been reported. The data from these studies "are consistent with a lifetime cancer risk resulting from exposure during gestation which is two to three times that for the adult" (NCRP Report No.

116, Ref. 2). The NRC has reviewed the available scientific literature and has concluded that the 0.5 rem

(5 mSv) limit specified in 10 CFR 20.1208 provides an adequate margin of protection for the embryo/fetus.

This dose limit reflects the desire to limit the total life time risk of leukemia and other cancers associated with radiation exposure during pregnancy.

In order for a pregnant worker to take advantage of the lower exposure limit and dose monitoring provi sions specified in 10 CFR Part 20, the woman must de clare her pregnancy in writing to the licensee. A form letter for declaring pregnancy is provided in this guide or the licensee may use its own form letter for declaring pregnancy. A separate written declaration should be submitted for each pregnancy.

C. REGULATORY POSITION

1. Who Should Receive Instruction Female workers who require training under 10

CFR 19.12 should be provided with the information contained in this guide. In addition to the information contained in Regulatory Guide 8.29 (Ref. 1), this infor mation may be included as part of the training required under 10 CFR 19.12.

2. Providing Instruction The occupational worker may be given a copy of this guide with its Appendix, an explanation of the con tents of the guide, and an opportunity to ask questions and request additional information. The information in this guide and Appendix should also be provided to any worker or supervisor who may be affected by a declara tion of pregnancy or who may have to take some action in response to such a declaration.

Classroom instruction may supplement the written information. If the licensee provides classroom instruc tion, the instructor should have some knowledge of the biological effects of radiation to be able to answer ques tions that may go beyond the information provided in this guide. Videotaped presentations may be used for classroom instruction. Regardless of whether the li censee provides classroom training, the licensee should give workers the opportunity to ask questions about in formation contained in this Regulatory Guide 8.13. The licensee may take credit for instruction that the worker has received within the past year at other licensed facili ties or in other courses or training.

3. Licensee's Policy on Declared Pregnant Women The instruction provided should describe the li censee's specific policy on declared pregnant women, including how those policies may affect a woman's work situation. In particular, the instruction should in clude a description of the licensee's policies, if any, that may affect the declared pregnant woman's work situa tion after she has filed a written declaration of pregnan cy consistent with 10 CFR 20.1208.

The instruction should also identify who to contact for additional information as well as identify who should receive the written declaration of pregnancy.

The recipient of the woman's declaration may be identi fied by name (e.g., John Smith), position (e.g., immedi ate supervisor, the radiation safety officer), or depart ment (e.g., the personnel department).

4. Duration of Lower Dose Limits for the Embryo/

Fetus The lower dose limit for the embryo/fetus should remain in effect until the woman withdraws the declaration in writing or the woman is no longer preg nant. If a declaration of pregnancy is withdrawn, the dose limit for the embryo/fetus would apply only to the time from the estimated date of conception until the time the declaration is withdrawn. If the declaration is

8.13-2 L

not withdrawn, the written declaration may be consid ered expired one year after submission.

5. Substantial Variations Above a Uniform Month ly Dose Rate According to 10 CFR 20.1208(b), "The licensee 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 section," that is, 0.5 rem (5 mSv) to the embryo/fetus.

The National Council on Radiation Protection and Measurements (NCRP) recommends a monthly equiv alent dose limit of 0.05 rem (0.5 mSv) to the embryo/

fetus once the pregnancy is known (Ref. 2). In view of the NCRP recommendation, any monthly dose of less than 0.1 rem (1 mSv) may be considered as not a sub stantial variation above a uniform monthly dose rate and as such will not require licensee justification. How ever, a monthly dose greater than 0.1 rem (1 mSv)

should be justified by the licensee.

D. IMPLEMENTATION

The purpose of this section is to provide informa tion to licensees and applicants regarding the NRC

staff's plans for using this regulatory guide.

Unless a licensee or an applicant proposes an ac ceptable alternative method for complying with the specified portions of the NRC's regulations, the meth ods described in this guide will be used by the NRC

staff in the evaluation of instructions to workers on the radiation exposure of pregnant women.

REFERENCES

1.

USNRC, "Instruction Concerning Risks from Oc cupational Radiation Exposure,"

Regulatory Guide 8.29, Revision 1, February 1996.

2.

National Council on Radiation Protection and Measurements, Limitation of Exposure to Ioniz ing Radiation, NCRP Report No. 116, Bethesda, MD, 1993.

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APPENDIX

QUESTIONS AND ANSWERS CONCERNING PRENATAL RADIATION EXPOSURE

1. Why am I receiving this information?

The NRC's regulations (in 10 CFR 19.12, "Instruc tions to Workers") require that licensees instruct indi viduals working with licensed radioactive materials in radiation protection as appropriate for the situation.

The instruction below describes information that occu pational workers and their supervisors should know about the radiation exposure of the embryo/fetus of pregnant women.

The regulations allow a pregnant woman to decide whether she wants to formally declare her pregnancy to take advantage of lower dose limits for the embryo/

fetus. This instruction provides information to help women make an informed decision whether to declare a pregnancy.

2. If I become pregnant, am I required to declare my pregnancy?

No. The choice whether to declare your pregnancy is completely voluntary. If you choose to declare your pregnancy, you must do so in writing and a lower radi ation dose limit will apply to your embryo/fetus. If you choose not to declare your pregnancy, you and your embryo/fetus will continue to be subject to the same radiation dose limits that apply to other occupational workers.

3. If I declare my pregnancy in writing, what happens?

If you choose to declare your pregnancy in writing, the licensee must take measures to limit the dose to your embryo/fetus to 0.5 rem (5 millisievert) during the entire pregnancy. This is one-tenth of the dose that an occupational worker may receive in a year. If you have already received a dose exceeding 0.5 rem (5 mSv) in the period between conception and the declaration of your pregnancy, an additional dose of 0.05 rem (0.5 mSv) is allowed during the remainder of the pregnancy.

In addition, 10 CFR 20.1208, "Dose to an Embryo/

Fetus," requires licensees to make efforts to avoid sub stantial variation above a uniform monthly dose rate so that all the 0.5 rem (5 mSv) allowed dose does not occur in a short period during the pregnancy.

This may mean that, if you declare your pregnancy, the licensee may not permit you to do some of your nor mal job functions if those functions would have al lowed you to receive more than 0.5 rem, and you may not be able to have some emergency response responsibilities.

4. Why do the regulations have a lower dose limit for the embryo/fetus of a declared pregnant woman than for a pregnant worker who has not declared?

A lower dose limit for the embryo/fetus of a de clared pregnant woman is based on a consideration of greater sensitivity to radiation of the embryo/fetus and the involuntary nature of the exposure. Several scientif ic advisory groups have recommended (References 1 and 2) that the dose to the embryo/fetus be limited to a fraction of the occupational dose limit.

5. What are the potentially harmful effects of radi ation exposure to my embryo/fetus?

The occurrence and severity of health effects caused by ionizing radiation are dependent upon the type and total dose of radiation received, as well as the time period over which the exposure was received. See Regulatory Guide 8.29, "Instruction Concerning Risks from Occupational Exposure" (Ref. 3), for more infor mation. The main concern is embryo/fetal susceptibil ity to the harmful effects of radiation such as cancer.

6. Are there any risks of genetic defects?

Although radiation injury has been induced experi mentally in rodents and insects, and in the experiments was transmitted and became manifest as hereditary dis orders in their offspring, radiation has not been identi fied as a cause of such effect in humans. Therefore, the risk of genetic effects attributable to radiation exposure is speculative. For example, no genetic effects have been documented in any of the Japanese atomic bomb survivors, their children, or their grandchildren.

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 at all to occupational radiation dose, but your employer is not obligated to provide you with ajob involving no radiation exposure. Even if you receive no occupational exposure at all, your embryo/

fetus will receive some radiation dose (on average 75 mrem (0.75 mSv)) during your pregnancy from natural background radiation.

The NRC has reviewed the available scientific lit erature and concluded that the 0.5 rem (5 mSv) limit

8.13-4 I

I

provides an adequate margin of protection for the embryo/fetus. This dose limit reflects the desire to lim it the total lifetime risk of leukemia and other cancers.

If this dose limit is exceeded, the total lifetime risk of cancer to the embryo/fetus may increase incrementally.

However, the decision on what level of risk to accept is yours. More detailed information on potential risk to the embryo/fetus from radiation exposure can be found in References 2-10.

8. What effect will formally declaring my pregnan cy have on my job status?

Only the licensee can tell you what effect a written declaration of pregnancy will have on your job status.

As part of your radiation safety training, the licensee should tell you the company's policies with respect to the job status of declared pregnant women. In addition, before you declare your pregnancy, you may want to talk to your supervisor or your radiation safety officer and ask what a declaration of pregnancy would mean specifically for you and your job status.

In many cases you can continue in your present job with no change and still meet the dose limit for the embryo/fetus. For example, most commercial power reactor workers (approximately 93%) receive, in 12 months, occupational radiation doses that are less than

0.5 rem (5 mSv) (Ref. 11). The licensee may also con sider the likelihood of increased radiation exposures from accidents and abnormal events before making a decision to allow you to continue in your present job.

If your current work might cause the dose to your embryo/fetus to exceed 0.5 rem (5 mSv), the licensee has various options. It is possible that the licensee can and will make a reasonable accommodation that will al low you to continue performing your current job, for example, by having another qualified employee do a small part of the job that accounts for some of your radi ation exposure.

9. What information must I provide in my written declaration of pregnancy?

You should provide, in writing, your name, a decla ration 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 the licensee. A

form letter that you can use is included at the end of these questions and answers. You may use that letter, use a form letter the licensee has provided to you, or write your own letter.

10. To declare my pregnancy, do I have to have doc umented medical proof that I am pregnant?

NRC regulations do not require that you provide medical proof of your pregnancy. However, NRC regu lations do not preclude the licensee from requesting medical documentation of your pregnancy, especially if a change in your duties is necessary in order to com ply with the 0.5 rem (5 mSv) dose limit.

11. Can I tell the licensee orally rather than in writ ing that I am pregnant?

No. The regulations require that the declaration must be in writing.

12. If I have not declared my pregnancy in writing, but the licensee suspects that I am pregnant, do the lower dose limits apply?

No. The lower dose limits for pregnant women ap ply only if you have declared your pregnancy in writ ing. The United States Supreme Court has ruled (in United Automobile Workers International Union v.

Johnson Controls, Inc., 1991) that "Decisions about the welfare of future children must be left to the parents who conceive, bear, support, and raise them rather than to the employers who hire those parents" (Reference 7).

The Supreme Court also ruled that your employer may not restrict you from a specific job "because of concerns about the next generation." Thus, the lower limits ap ply only if you choose to declare your pregnancy in writing.

13. If I am planning to become pregnant but am not yet pregnant and I inform the licensee of that in writing, do the lower dose limits apply?

No. The requirement for lower limits applies only if you declare in writing that you are already pregnant.

14. What if I have a miscarriage or find out that I

am not pregnant?

If you have declared your pregnancy in writing, you should promptly inform the licensee in writing that you are no longer pregnant. However, if you have not formally declared your pregnancy in writing, you need not inform the licensee of your nonpregnant status.

15. How long is the lower dose limit in effect?

The dose to the embryo/fetus must be limited until you withdraw your declaration in writing or you inform the licensee in writing that you are no longer pregnant.

If the declaration is not withdrawn, the written decla ration may be considered expired one year after submission.

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16. 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 limit for the embryo/fetus no longer applies.

17. What if I work under contract at a licensed facility?

The regulations state that you should formally de clare your pregnancy to the licensee in writing. The li censee has the responsibility to limit the dose to the embryo/fetus.

18. Where can I get additional information?

The references to this Appendix contain helpful in formation, especially Reference 3, NRC's Regulatory Guide 8.29, "Instruction Concerning Risks from Occu pational Radiation Exposure," for general information on radiation risks. The licensee should be able to give this document to you.

For information on legal aspects, see Reference 7,

"The Rock and the Hard Place: Employer Liability to Fertile or Pregnant Employees and Their Unborn Chil dren-What Can the Employer Do?" which is an article in the journal Radiation Protection Management.

You may telephone the NRC Headquarters at (301)

415-7000. Legal questions should be directed to the Office of the General Counsel, and technical questions should be directed to the Division of Industrial and Medical Nuclear Safety.

You may also telephone the NRC Regional Offices at the following numbers: Region I, (610) 337-5000;

Region II, (404) 562-4400; Region III, (630) 829-9500;

and Region IV, (817) 860-8100. Legal questions should be directed to the Regional Counsel, and technical questions should be directed to the Division of Nuclear Materials Safety.

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REFERENCES FOR APPENDIX

1.

National Council on Radiation Protection and Measurements, Limitation of Exposure to Ioniz ing Radiation, NCRP Report No. 116, Bethesda, MD, 1993.

2.

International Commission on Radiological Protection, 1990 Recommendations of the Inter national Commission on Radiological Protec tion, ICRP Publication 60, Ann. ICRP 21: No.

1-3, Pergamon Press, Oxford, UK, 1991.

3.

USNRC, "Instruction Concerning Risks from Occupational Radiation Exposure," Regulatory Guide 8.29, Revision 1, February 1996.1 (Elec tronically available at www.nrc.gov/NRC/RG/

index.html)

4.

Committee on the Biological Effects of Ionizing Radiations, National Research Council, Health Effects of Exposure to Low Levels of Ionizing Radiation (BEIR V), National Academy Press, Washington, DC, 1990.

5.

United Nations Scientific Committee on the Ef fects of Atomic Radiation, Sources and Effects of Ionizing Radiation, United Nations, New York,

1993.

'Single copies of regulatory guides, both active and draft, and draft NUREG documents may be obtained free of charge by writing the Reproduction and Distribution Services Section, OCIO, USNRC,

Washington, DC 20555-0001, or by fax to (301)415-2289, or by email to <DISTRIBUTION@NRC.GOV>. Active guides may also be purchased from the National Technical Information Service on a standing order basis. Details on this service may be obtained by writ ing NTIS, 5285 Port Royal Road, Springfield, VA 22161. Copies of active and draft guides are available for inspection or copyingfor a fee from the NRC Public Document Room at 2120 L Street NW, Wash ington, DC; the PDR's mailing address is Mail Stop LL-6, Washing ton, DC 20555; telephone (202)634-3273: fax (202)634-3343.

6.

R. Doll and R. Wakeford, "Risk of Childhood Cancer from Fetal Irradiation," The British Jour nal of Radiology, 70, 130-139, 1997.

7.

David Wiedis, Donald E. Jose, and Timm 0.

Phoebe, "The Rock and the Hard Place: Employ er Liability to Fertile or Pregnant Employees and Their Unborn Children-What Can the Employer Do?" Radiation Protection Management, 11,

41-49, January/February 1994.

8.

National Council on Radiation Protection and Measurements, Considerations Regarding the Unintended Radiation Exposure of the Embryo, Fetus, orNursing Child, NCRP Commentary No.

9, Bethesda, MD, 1994.

9.

National Council on Radiation Protection and Measurements, Risk Estimates for Radiation Protection, NCRP Report No. 115, Bethesda, MD, 1993.

10. National Radiological Protection Board, Advice on Exposure to lonising Radiation During Preg nancy, National Radiological Protection Board, Chilton, Didcot, UK, 1998.

11.

M.L. Thomas and D. Hagemeyer, "Occupational Radiation Exposure at Commercial Nuclear Pow er Reactors and Other Facilities, 1996," Twenty Ninth Annual Report, NUREG-0713, Vol. 18, USNRC, 1998.2

2Copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402- 9328 (tele phone (202)512-1800); or from the National Technical Information Service by writing NTIS at 5285 Port Royal Road, Springfield, VA

22161. Copies are available for inspection or copying for a fee from the NRC Public Document Room at 2120 LStreet NW, Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC

20555; telephone (202)634-3273; fax (202)634-3343.

8.13-7

FORM LETTER FOR DECLARING PREGNANCY

This form letter is provided for your convenience. To make your written declaration of pregnancy, you may fill in the blanks in this form letter, you may use a form letter the licensee has provided to you, or you may write your own letter.

DECLARATION OF PREGNANCY

To:

In accordance with the NRC's regulations at 10 CFR 20.1208, "Dose to an Embryo/Fetus," I am declaring that I am pregnant. I believe I became pregnant in (only the month and year need be provided).

I understand the radiation dose to my embryo/fetus during my entire pregnancy will not be allowed to ex ceed 0.5 rem (5 millisievert) (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.

(Your signature)

(Your name printed)

(Date)

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REGULATORY ANALYSIS

A separate regulatory analysis was not prepared for this regulatory guide. A regulatory analysis prepared for 10 CFR Part 20, "Standards for Protection Against Radiation" (56 FR 23360), provides the regulatory ba sis for this guide and examines the costs and benefits of the rule as imple mented by the guide. A copy of the "Regulatory Analysis for the Revision of 10 CFR Part 20" (PNL-6712, November 1988) is available for inspec tion and copying for a fee at the NRC Public Document Room, 2120 L

Street NW, Washington, DC, as an enclosure to Part 20 (56 FR 23360).

8.13-9

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