ML20195J102

Rev 3 to Reg Guide 8.13,task DG-8014, Instructions Re Prenatal Radiation Exposure

ML20195J102
Person / Time
Issue date:	06/30/1999
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
References
TASK-*****, TASK-RE REGGD-08.013, REGGD-8.013, NUDOCS 9906180089
Download: ML20195J102 (12)

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1. co U.S. NUCLEAR REGULATORY COMMISSION Revision 3 g June 1999 g/gg) REGULATORY GU DE

**** OFFICE OF NUCLEAR REGULATORY RESEARCH REGULATORY GUIDE 8.13 (Draft was issued as DG-8014)

INSTRUCTION CONCERNING PRENATAL RADIATION EXPOSURE A. INTRODUCTION This regulatory guide is intended to provide infor-mation to pregnant women, and otherpersonnel, to help The Code of Federal Regulations in 10 CFR Part them make decisions regarding radiation exposure dur-19," Notices, Instructions and Reports to Workers: In-ing pregnancy. This Regulatory Guide 8.13 supple-spection and Investigations," in Section 19.12, "In-ments Regulatory Guide 8.29," Instruction Concerning structions to Workers," requires instruction in "the Risks from Occupational Radiation Exposure"(Ref.

health protection problems associated with exposure t 1), which contains a broad discussion of the risks from radiation and/or radioactive material,in precautions or exposure to ionizing radiation.

procedures to minimize exposure, and in the purposes and functions of protective devices employed." The in-Other sections of the NRC's regulations also speci-structions must be " commensurate with potential ra-fy requirements for monitoring external and internal diological health protection problems present in the occupational dose to a declared pregnant woman. In 10 work place.

) CFR 20.1502, " Conditions Requiring Individual Mon-The Nuclear Regulatory Commission's (NRC's) itoring of External and Internal Occupational Dose,"li-regulations on radiation protection are specified in 10 censees are required to monitor the occupational dose CFR Part 20," Standards for Protection Against Radi- to a declared prenant woman, using an individual ation"; and 10 CFR 20.1208, " Dose to an Embryo / monitoring device, illt is likely that the declared preg-Fetus," requires licensees to " ensure that the dose to an nant woman will receive, from external sources, a deep embryo / fetus during the entire pregnancy, due to occu-pational exposure of a declared pregnant woman, does dose equivalent ing to Paragraph (c) of 10in CFR excess20.2106, of " Records 0.1 rem of (1 mSv). Acco not exceed 0.5 rem (5 mSv)." Section 20.1208 also re. Individual Monitoring Results," the licensee must b quires licensees to "make efforts to avoid substantial maintain records of dose to an embryo / fetus if monitor-variation above a uniform monthly exposure rate to a ing was required, and the records of dose to the embryo // fj declared pregnant woman." A declared pregnant fetus must be kept with the records of dose to the de- ~

wornan is defined in 10 CFR 20.1003 as a woman who clared pregnant woman. The declaration of pregnancy has voluntarily informed her employer, in writing, of must be kept on file, but may be maintained separately her pregnancy and the estimated date of conception. from the dose records. The licensee must retain the re-USNRC REGULAToRYGUIDES The gwdes are saeued in the follomng ten twood divisons nonas to C st or ms ng the om. 1 Power Reactors 6. Products O'"""a*l:aa:".,=,=%Cn"C'==l:Pe = = C ' Po" = fl':s" = . i &*:' Pses,tn

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Single copses of regulatory gudes may be obtened free of charDe by wnting to the Repro-This Guide was assued aher canadoretion of comments received from the pubhc Com- stn n , ear eg o p R8 monts and suggest one forsmprovements in these gwdes are encouraged at afi times, and gudos mil be revised. as appropnate, to accomrnodato conwnents and to reflect new m-gy be submitted to the Rules and Oweetives Branch, ADM. U S a order tfa. a on c be obtm T S Nuclear Regulatory Conmason, WasNngton, DC 205554001. Royal Road. Spt'ngfield VA 22161.

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quired form or record until the Commission terminates contained in Regulatory Guide 8.29 (Ref.1), this infor-each pertinent license requiring the record, mation may be included as part of the training required under 10 CFR 19.12.

The information collections in this regulatory guide are covered by the requirements of 10 CFR Parts 2. Providing Instruction 1 19 or 20, which were approved by the Office of Man- The occupational worker may be given a copy of agement and Budget, approval numbers 3150-0044 and this guide with its Appendix, an explanation of the con-3150-0014, respectively. The NRC may not conduct or tents of the guide, and an opportunity to ask questions sponsor, and a person is not required to respond to, a and request additional information. The information in collection ofinformation unless it displays a currently this guide and Appendix should also be provided to any valid OMB control number. worker or supervisor w ho may be affected by a declara-H. DISCUSSION tion of pregnancy or who may have to take some action in response to such a declaration.

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

Classroom instruction may supplement the written exposure to any level of radiation is assumed to carry .

inf rmation. If the licensee provides classroom instruc-with it a certain amount of risk. In the absence of scien-tion, the mstructor should have some knowledge of the tific ce-tainty regarding the relationship between low biological effects of radiation to be able to answer qt.c .-

dose exposure and health effects, and as a conservative tions that may go beyond the information provided .n assumption for radiation protection purposes, the this guide. Videotaped presentations may be used for scientific community generally assumes that any expo- ,

ci ssmom 1nstmetion. Regardless of whether the li-sure to ionizing radiation may cause undesirable bio- ,

censee pmvides classroom training, the licensee should logical effects and that the likelihood of these effects in-give w rkers the opportunity to ask questions about in-creases as the dose increases. At the occupational dose f rmation contamedin this Regulatory Guide 8.13.The limit for the whole body of 5 rem (50 mSv) per year, the licensee may take credit for instruction that the worker risk is believed to be very low.

has received within the past year at other licensed facili-The magnitude of risk of childhood cancer follow- ties or in other courses or training.

ing in utero exposure is uncertain in that both negative

3. Licensee's Policy on Decland Pirgnant Women and positive studies have been reported. The data from these studies "are consistent with a lifetime cancer risk The instruction provided should describe the li-resulting from exposure during gestation which is two censee's specific policy on declared pregnant women, to three times that for the adult" (NCRP Report No. including how those policies may affect a woman's 116, Ref. 2). The NRC has reviewed the available work situation. In particular, the instruction should in-scientific literature and has concluded that the 0.5 rem clude a description of the licensee's policies,if any,that (5 mSv) limit specified in 10 CFR 20.1208 provides an may affect the declared pregnant woman's A rk situa-adequate margin of protection for the embryo / fetus. tion after she has filed a written declaration of pregnan-This dose limit reflects the desire to limit the totallife. cy consistent with 10 CFR 20.1208. j time risk ofleukemia and other cancers associated with The instruction should also identify who to contact radiation exposure during pregnancy. for additional information as well as identify' who In order for a pregnant worker to take advantage of should receive the written declaration of pregnancy.

the lower exposure limit and dose monitoring provi. The recipient of the woman's declaration may be identi-sions specified in 10 CFR Part 20, the woman must de. fied by name (e.g., John Smith), position (e.g., immedi-clare her pregnancy in writing to the licensee. A form ate supervisor, the radiation safety officer), or depart-letter for declaring pregnancy is provided in this guide ment (e.g., the personnel department).

or the licensee may use its own form letter for declaring 4. Duration of Lower Dose Limits for the Embryo /

pregnancy. A separate written declaration should be Fetus submitted for each pregnancy.

The lower dose limit for the embryo / fetus should C. REGULATORY POSITION remain in effect ratil the woman withdraws the declaration in writing or the woman is no longer preg-

1. Who Should Receive Instruction nant. If a declaration of pregnancy is withdrawn, the Female workers who require training under 10 dose limit for the embryo / fetus would apply only to the CFR 19.12 should be provided with the information time from the estimated date of conception until the contained in this guide. In addition to the information time the declaration is withdrawn. If the declaration is 8.13 - 2

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

The purpose of this section is to provide informa-

\ 5. Substantial Variations Above a Uniform Month, tion to licensees and applicants regarding the NRC

(,) ly Dose Rate staff's plans for using this regulatory guide.

Unless a licensee or an applicant proposes an ac-According to 10 CFR 20.1208(b),"The licensee ceptable alternative method for complying with the shall make efforts to avoid substantial variation above a specified portions of the NRC's regulations, the meth-uniform monthly exposure rate to a declared pregnant ods described in this guide will be used by the NRC woman so as to satisfy the limit in paragraph (a) of this staffin the evaluation ofinstructio.?s to workers on the section," that is,0.5 rem (5 mSv) to the embryo / fetus. radiation exposure of pregnant women.

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

1. USNRC," Instruction Concerning Risks from Oc-fetus once the pregnancy is known (Ref. 2). In view of the NCRP recommendation, any monthly dose ofless cupational Radiation Exposure," Regulatory than 0.1 rem (1 mSv) may be considered as not a sub- Guide 8.29, Revision 1, February 1996.

stantial variation above a uniform monthly dose rate 2. National Council on Aadiation Protection and and as such will not require licensee j ustification. How- Measurements, Limitation of Exposure to Ioniz-ever, a monthly dose greater than 0.1 rem (1 mSv) ing Radiation, NCRP Report No.116, Bethesda, should be justified by the licensee. MD,1993.

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APPENDl?.

i QUESTIONS AND ANSWERS CONCERNING PRENATAL RADIATION EXPOSURE

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1. Why am I treeiving this information? not be able to have some emergency response responsibilities.

The NRC's regulations (in 10 CFR 19.12,"Instruc-tions to Workers") require that licensees instruct indi. 4. Why do the regulations have a lower dose limit viduals working with licensed radioactive materials in for the embryo / fetus of a declared pregnant radiation protection as appropriate for the situation, woman than for a pirgnant worker who has not The instruction below describes information that occu- declarrd?

pational workers and their supervisors should know A lower dose limit for the embryo / fetus of a de-about the radiation exposure of the embryo / fetus of clared pregnant woman is based on a consideration of pregnant women. greater sensitivity to radiation of the embryo / fetus and The regulations allow a pregnant woman to decide the involuntary nature of the exposure. Several scientif-whether she wants to formally declare her pregnancy to ic advisory groups have recommended (References 1 take advantage of lower dose limits for the embryo / and 2) that the dose to the embryo / fetus be limited to a fetus. This instruction provides information to help fraction of the occupational dose limit.

women make an informed decision whether to declare a 5. What are the potentially harmful effects of radi.

pregnancy. ation exposure to my embryo / fetus?

2. If I become prrgnant, am I required to declare The occurrence and severity of health effects  ;

my pregnancy? caused by ionizing radiation are dependent upon the l No. The choice whether to declare your pregnancy type and total dose of radiation received, as well as the is completely voluntary. If you choose to declare your time period over which the exposure was received. See pregnancy, you must do so in writing and a lower radi- Regulatory Guide 8.29, " Instruction Concerning Risks ation dose limit will apply to your embryo / fetus. If you fr m Occupational Exposure"(Ref. 3), for more infor-choose not to declare your pregnancy, you and your m tion. The main concern is embryo / fetal susceptibil-embryo / fetus will continue to be subject to the same ity to the harmful effects of radiation such as cancer.

radiation dose limits that apply to other occupational 6. Air the:r any risks of genetic defects?

w rkers. Although radiation injury has been inJuced experi-

3. If I declair my prrgnancy in writing, what mentally in rodents and insects, and in the experiments happens? was transmitted and became manifest as hereditary dis-orders in their offspring, radiation has not been identi-If you choose to declare your pregnancy in writing, fied as a cause of such effect in humans. Therefore, the the licensee must take measures to limit the dose t risk of genetic effects attributable to radiation exposure your embryo / fetus to 0.5 rem (5 milhsievert) during the is speculative. For example, no genetic effects' have entire pregnancy. This is one-tenth of the dose that an been documented in any of the Japanese atomic bomb occupational worker may receive in a year. If you have survivors, their children, or their grandchildren. -

already received a dose exceeding 0.5 rem (5 mSv)in the period between conception and the declaration of 7. What ifI decide that I do not want any radiation your pregnancy, an additional dose of 0.05 rem (0.5 exposure at all during my pregnancy?

mSv)is allowed during the remainder of the pregnancy. You may ask your employer for a job that does not In addition,10 CFR 20.1208, " Dose to an Embryo / involve any exposure at all to occupational radiation i Fetus," requires licensees to make efforts to avoid sub- dose, but your employer is not obligated to provide you stantial variation above a uniform monthly dose rate so with a job involving no radiation exposure. Even if you that all the 0.5 rem (5 mSv) allowed dose does not occur receive no occupational exposure at all, your embryo /

in a short period during the pregnancy. fetus will receive some radiation dose (on average 75 This may mean that,if you declare your pregnancy, mrem (0.75 mSv)) during your pregnancy from natural the licensee may not permit you to do some of your nor- background radiation.

mal job functions if those functions would have al- The NRC has reviewed the available scientific lit-lowed you to receive more than 0.5 rem, and you may erature and concluded that the 0.5 rem (5 mSv) limit 8.13 - 4 1

provides an adequate margin of protection for the 10. To declim my pngnancy, do I have to h:ve doc-embryo / fetus. This dose limit reflects the desire to lim- umented medical pmof that I am pngnant?

it the total lifetime risk of leukemia and other cancers.

If this dose limit is exceeded, the total lifetime risk of NRC regulations do not require that you provide

) medical proof of your pregnancy. liowever, NRC regu-v cancer to the embryo / fetus may increase incrementally.

lations do not preclude the licensee from requesmg liowever, the decision on what level of risk to accept is medical documentation of your pregnancy, especiaJy yours. More i tailed informatmn on potential risk to if a change in your duties is necessary in order to com-the embryo / fetu from radiation exposure can be found ply w th the 0.5 rem (5 mSv) dose limit.

m References 2-10.

11. Can I tell the licensee orally rather than in writ-

8. What effect will formally declaring my pregnan- ing that I am pregnant?

cy have on myjob status?

No. The regulations require that the declaration Only the licensee can tell you what effect a written must be in wMng.

declaration of pregnancy will have on your job status. 12. IfI have not declared my pregnancy in writing, As part of your radiation safety training, the licensee but the licensee suspects that I am pngnant, do should tell you the company's policies with respect to the lower dose limits apply?

thejob status of declared pregnant women. In addition, before you declare your pregnancy, you may want to No. The lower dose limits for pregnant women ap-talk to your supervisor or your radiation safety officer ply nly if you have declared your pregnancy m writ-and ask what a declaration of pregnancy would mean ing. The United States Supreme Court has ruled (m specifically for you and yourjob status. United Automobile Workers International Union u Johnson Controls, Inc.,1991) that "Decumns about the In many cases you can continue in your present job welf re of future children must be left to the parents with no change and still meet the dose limit for the who conceive, bear, support, and raise them rather than embryo / fetus. For example, most commercial power t the employers who hire those parents"(Reference 7).

reactor workers (approximately 93%) receive, in 12 The Supreme Court also ruled that your employer may O months, occupational radiation doses that are less than 0.5 rern (5 mSv)(Ref.11). The licensee may also con-n t restrict you from a specificjob"because ofconcerns about the next generation." Thus, the lower limits ap-ply nly if you choose to declare your pregnancy in sider the likelihood of increased radiation exposures from accidents and abnormal events before making a writing.

6 Mon to allow you to continue in your present job.

13. IfI am planning to become pregnant but am not

. yet pregnant and I inform the licensee of that in If your current work might cause the dose to your writing, do the lower dose limits apply?

embryo / fetus to exceed 0.5 rem (5 mSv), the licensee has various options. It is possible that the licensee can No. The requirement for lower limits applies only and will make a reasonable accommodation that will al. if you declare in writing that you are already pregnant.

Iow you to continue performing your current job, for

14. What ifI have a miscarriage or find out that I example, by having another qualified employee do a am not pregnant?

small part of thejob that accounts for some ofyour radi-ation exposure, if you have declared your pregnancy in writing, you should promptly inform the licensee .a writing that

9. What information must I pmvide in my written you are no longer pregnant. Ilowever,if you have not declaration of pngnancy? formally declared your pregnancy in writing, you need not inform the licensee of your nonpregnant status.

You should provide, in writing, your name, a decla-ration that you are pregnant, the estimated date of 15. Ilow long is the lower dose limit in effect?

conception (only the month and year need be given), The dose to the embryo / fetus must be limited until and the date that you give the letter to the licensee. A you withdraw your declaration in writing or you inform form letter that you can use is included at the end of the licensee in writing that you are no longer pregnant.

these questions and answers. You may use that letter, v) if the declaration is not withdrawn, the written decla-s use a form letter the licensee has provided to you, or ration may be considered expired one year after write your own letter. submission.

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16. If I h:ve declared my pregnancy in writing, can on radiation risks. The licensee should be able to give I revoke my declaration of pregnancy even if I this document to you.

am still pregnant?

For information on legal aspects, see Reference 7, 1 Yes, you may. The choice is entirely yours. If you "The Rock and the liard Place: Employer Liability to revoke your declaration of pregnancy, the lower dose Fertile or Pregnant Employees and Their Unborn Chil-

, limit for the embryo / fetus no longer applies. dren-What Can the Employer Do?"v'hich is an article in the journal Radiation Protection Management.

17. W la if I work under contract at a licensed You may telephone the NRC lieadquarters at (301) 415-7000. Legal questions should be directed to the The regulations state that you should formally de- Office of the General Counsel, and technical questions clare your pregnancy to the licensee in writing. The li- should be directed to the Division of Industrial and censee has the responsibility to limit the dose to the Medical Nuclear Safety.

embryo / fetus.

You may also telephone the NRC Regional Offices

18. Where can I get additional information? at the following numbers: Region I, (610) 337-5000; Region 11, (404) 562-4400; Region III, (630) 829-9500; The references to this Appendix contain helpfulin- and Region IV, (817) 860-8100. Legal questions should formation, especially Reference 3, NRC's Regulatory be directed to the Regional Counsel, and technical Guide 8.29," Instruction Concerning Risks from Occu- questions should be directed to the Division of Nuclear pational Radiation Exposure," for general information Materials Safety.

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REFERENCES FOR APPENDIX

, 1. National Council on Radiation Protection and 6. R. Doll and R. Wakeford, " Risk of Childhood Measurements, Limitation of Exposure to Ioni:- Cancer from Fetal Irradiation," The British Jour-lmV) ing Radiation, NCRP Report No.116, Bethesda, nal ofRadiology,70,130-139,1997.

MD,1993.

7. David Wiedis, Donald E. Jose, and Timm O.

2. International Commission on Radiological Phoebe,"The Rock and the Hand Place: Employ-Protection,1990 Recommendations of the Inter- er Liability to Fertile or Pregnant Employees and national Commission on . Radiological Protec- Their Unborn Children-What Can the Employer tion, ICRP Publication 60, Ann. ICRP 21: No. Do?" Radiation Protection Management,11, 1-3, Pergamon Press, Oxford, UK,1991. 41-49, January / February 1994.

3. USNRC, " Instruction Concerning Risks from 8. National Council on Radiation Protection and Occupational Radiation Exposure," Regulatory Measurements, Considerations Regarding the Guide 8.29, Revision 1, February 1996.1 (Elec- Unintended Radiation Exposure of the Embryo, tronically available at www.nrc. gov /NRC/RG/ Fetus, orNursing Child, NCRP Commentary No.

index.html) 9, Bethesda, MD,1994.

4. Committee on the Biological Effects ofIonizing 9. National Council on Radiation Protection and Radiations, National Research Council, IIcalth Measurements, Risk Estimates for Radiation Effects of Exposure to Low Levels ofIonizing Protection, NCRP Report No.115, Bethesda, Radiation (BEIR V), National Academy Press, MD,1993.

Washington, DC,1990.

10. National Radiological Protection Board, Advice

5. United Nations Scientific Committee on the Ef- on Exposure to lonising Radiation During Preg-fects of Atomic Radiation, Sources and Effects of nancy, National Radiological Protection Board, Ionizing Radiation, United Nations, New York, Chilton, Didcot, UK,1998.

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('j 1993.

11. M.L. Thomas and D. Hagemeyer," Occupational Radiation Exposure at Commercial Nuclear Pow-er Reactors and Other Facilities,1996," Twenty-ISingle copies of regulatory guides, both active and draft, and draft Ninth Annual Report, NUREG-0713, Vol.18, NUREG documents may be obtained free of charge by writing the Reproduction and Distribution Services Section, OClo, USNRC, USNRC' 1998*2 Washington, DC 20555-0001, or by fax to (301)415-2289, or by email to <DISTRIB UTION@NRC. GOV >. Active guides may also 2 Copies are available at current rates from the U.S. Government be purchased from the National Technical Information Service on a Printing Office, P.O. Box 37082, Washington, DC 20402 - 9328 (tele.

standing order basis. Details on this service may be obtained by writ- Phone (202)512- 1800); or from the National Techmcalinformation ing NTIS,5285 Port Royal Road, Springfield, VA 22161. Copies of Service by writing NTIS at 5285 Port Royal Road, Springfield. VA active and draft guides are available for inspection or copying for a fee 22161. Copies are available for inspection or copying for a fee from from the NRC Public Document Room at 2120 L Street NW., Wash. the NRCPublic Document Room at 2120 L Street NW., Washington, ington. DC; the PDR's mailing address is Mail Stop LL-6, Washing. DC: the PDR's mailing address is Mail Stop LL-6, Washmgton, DC ton. DC 20555; telephone (202)634 -3273: fax (202)634-3343, 20555; telephone (202)634 -3273; fax (202)634-3343.

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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) 1 l

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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 forinspec-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).

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