Regulatory Guide 8.13
| ML003739505 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/1999 |
| From: | Office of Nuclear Regulatory Research |
| To: | |
| References | |
| RG-8.13 | |
| Download: ML003739505 (11) | |
U.S. NUCLEAR REGULATORY COMMISSION Revision 3 June 1999 REGULATORY GUIDE
OFFICE OF NUCLEAR REGULATORY RESEARCH
REGULATORY GUIDE 8.13 (Draft was issued as DG-801 4)
INSTRUCTION CONCERNING PRENATAL RADIATION EXPOSURE
A. INTRODUCTION
This regulatory guide is intended to provide infor The Code of Federal Regulations in 10 CFR Part mation to pregnant women, and other personnel, to help
19, "Notices, Instructions and Reports to Workers: In them make decisions regarding radiation exposure dur spection and Investigations," in Section 19.12, "In ing pregnancy. This Regulatory Guide 8.13 supple structions to Workers," requires instruction in "the ments Regulatory Guide 8.29, "Instruction Conceming health protection problems associated with exposure to Risks from Occupational Radiation Exposure" (Ref.
radiation and/or radioactive material, in precautions or 1), which contains a broad discussion of the risks from procedures to minimize exposure, and in the purposes exposure to ionizing radiation.
and functions of protective devices employed." The in structions must be "commensurate with potential ra Other sections of the NRC's regulations also speci diological health protection problems present in the fy requirements for monitoring external and internal work place." occupational dose to a declared pregnant woman. In 10
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 pregnant woman, using an individual ation"; and 10 CFR 20.1208, "Dose to an Embryo/
monitoring device, if it 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 dose equivalent in excess of 0.1 rem (1 mSv). Accord pational exposure of a declared pregnant woman, does ing to Paragraph (e) of 10 CFR 20.2106, "Records of not exceed 0.5 rem (5 mSv)." Section 20.1208 also re Individual Monitoring Results," the licensee must 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/
declared pregnant woman." A declared pregnant fetus must be kept with the records of dose to the de woman 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 REGULATORY GUIDES
The guides are issued in the following ten broad divisions Regulatory Guides are issued to describe and make available to the tion as methods acceptable to the NRC staff for implementing specific public such informa parts of the Corn- 1. Power Reactors mission's regulations, techniques used by the staff in evaluating specific 6. Products problems or pos- 2. Research and Test Reactors tulated accidents, and data needed by the NRC staff in its review of 7. Transportation applications for per- mits and licenses. Regulatory guides are not substitutes for regulations, 3. Fuels and Materials Facilities and compliance
8. Occupational Health
4. Environmental and Siting 9. Antitrust and Financial Review with them is not required. Methods and solutions different from those set out in the guides 5- Materials and Plant Protection will be acceptable if they provide a basis forthe findings requisite to 10. General tinuance of a permit or license by the Commission. the issuance orcon 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.
mentsandsuggestionsforimprovementsintheseguidesareencouragedatalltimes, Corn- duction and Distribution Services Section, OCIO, U.S. Nuclear Regulatory Commission, and Washington, DC 20555-0001. or by fax to (301)415-2289; or by guides will be revised as appropriate, to accommodate comments and to e-mail to DISTRIBU
formation or experience. reflect new in- TION@NRC.GOV.
Issued guides may also be purchased from the National Written comments may be submitted to the Rules and Directives Technical Information Service Branch, ADM, U.S. a standing order basis. Details on this service may be obtained by writing on Nuclear Regulatory Commission, Washington, DC 20555-0001. NTIS, 5285 Port Royal Road, Springfield, VA 22161.
contained in Regulatory Guide 8.29 (Ref. 1), this infor quired form or record until the Commission terminates mation may be included as part of the training required each pertinent license requiring the record. under 10 CFR 19.12.
The information collections in this regulatory 2. Providing Instruction guide are covered by the requirements of 10 CFR Parts 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 of information unless it displays a currently this guide and Appendix should also be provided to any valid OMB control number. worker or supervisor who may be affected by a declara tion of pregnancy or who may have to take some action
B. DISCUSSION
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 information. If the licensee provides classroom instruc with it a certain amount of risk. In the absence of scien tion, the instructor should have some knowledge of the tific certainty regarding the relationship between low biological effects of radiation to be able to answer ques dose exposure and health effects, and as a conservative tions that may go beyond the information provided in assumption for radiation protection purposes, the this guide. Videotaped presentations may be used for scientific community generally assumes that any expo classroom instruction. Regardless of whether the li sure to ionizing radiation may cause undesirable bio censee provides classroom training, the licensee should logical effects and that the likelihood of these effects in give workers the opportunity to ask questions about in creases as the dose increases. At the occupational dose formation contained in 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 ties or in other courses or training.
The magnitude of risk of childhood cancer follow ing in utero exposure is uncertain in that both negative 3. Licensee's Policy on Declared Pregnant Women and positive studies have been reported. The data from The instruction provided should describe the li L
these studies "are consistent with a lifetime cancer risk censee's specific policy on declared pregnant women, resulting from exposure during gestation which is two including how those policies may affect a woman's to three times that for the adult" (NCRP Report No. work situation. In particular, the instruction should in
116, Ref. 2). The NRC has reviewed the available clude a description of the licensee's policies, if any, that scientific literature and has concluded that the 0.5 rem may affect the declared pregnant woman's work situa
(5 mSv) limit specified in 10 CFR 20.1208 provides an tion after she has filed a written declaration of pregnan adequate margin of protection for the embryo/fetus. cy consistent with 10 CFR 20.1208.
This dose limit reflects the desire to limit the total life The instruction should also identify who to contact time risk of leukemia and other cancers associated with for additional information as well as identify who radiation exposure during pregnancy.
should receive the written declaration of pregnancy.
In order for a pregnant worker to take advantage of The recipient of the woman's declaration may be identi the lower exposure limit and dose monitoring provi fied by name (e.g., John Smith), position (e.g., immedi sions specified in 10 CFR Part 20, the woman must de ate supervisor, the radiation safety officer), or depart clare her pregnancy in writing to the licensee. A form ment (e.g., the personnel department).
letter for declaring pregnancy is provided in this guide
4. Duration of Lower Dose Limits for the Embryo/
or the licensee may use its own form letter for declaring Fetus pregnancy. A separate written declaration should be submitted for each pregnancy. The lower dose limit for the embryo/fetus should remain in effect until the woman withdraws the
C. REGULATORY POSITION
declaration in writing or the woman is no longer preg
1. Who Should Receive Instruction nant. If a declaration of pregnancy is withdrawn, the dose limit for the embryo/fetus would apply only to the Female workers who require training under 10 time from the estimated date of conception until the CFR 19.12 should be provided with the information time the declaration is withdrawn. If the declaration is contained in this guide. In addition to the information
8.13-2
not withdrawn, the written declaration may be consid
D. IMPLEMENTATION
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 staff in the evaluation of instructions 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 REFERENCES
Measurements (NCRP) recommends a monthly equiv 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 cupational Radiation Exposure," Regulatory the NCRP recommendation, any monthly dose of less Guide 8.29, Revision 1, February 1996.
than 0.1 rem (1 mSv) may be considered as not a sub stantial variation above a uniform monthly dose rate 2. National Council on Radiation Protection and and as such will not require licensee justification. 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.
8.13-3
APPENDIX
QUESTIONS AND ANSWERS CONCERNING PRENATAL RADIATION EXPOSURE
1. Why am I receiving this information? not be able to have some emergency response I
The NRC's regulations (in 10 CFR 19.12, "Instruc responsibilities.
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 pregnant worker who has not The instruction below describes information that occu declared?
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 pregnant, am I required to declare The occurrence and severity of health effects my pregnancy? caused by ionizing radiation are dependent upon the 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 from Occupational Exposure" (Ref. 3), for more infor choose not to declare your pregnancy, you and your mation. The main concern is embryo/fetal susceptibil I
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. Are there any risks of genetic defects?
workers.
Although radiation injury has been induced experi
3. If I declare my pregnancy 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 to risk of genetic effects attributable to radiation exposure your embryo/fetus to 0.5 rem (5 millisievert) 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 if I 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 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 ajob 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
provides an adequate margin of protection for the 10. To declare my pregnancy, do I have to have doc embryo/fetus. This dose limit reflects the desire to lim umented medical proof that I am pregnant?
it the total lifetime risk of leukemia and other cancers.
NRC regulations do not require that you provide If this dose limit is exceeded, the total lifetime risk of medical proof of your pregnancy. However, NRC regu cancer to the embryo/fetus may increase incrementally.
lations do not preclude the licensee from requesting However, the decision on what level of risk to accept is medical documentation of your pregnancy, especially yours. More detailed information on potential risk to if a change in your duties is necessary in order to com the embryo/fetus from radiation exposure can be found ply with the 0.5 rem (5 mSv) dose limit.
in 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 my job status?
No. The regulations require that the declaration Only the licensee can tell you what effect a written must be in writing.
declaration of pregnancy will have on your job status. 12. If I have not declared my pregnancy in writing, As part of your radiation safety training, the licensee but the licensee suspects that I am pregnant, do should tell you the company's policies with respect to the lower dose limits apply?
the job 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 only if you have declared your pregnancy in writ and ask what a declaration of pregnancy would mean ing. The United States Supreme Court has ruled (in specifically for you and your job status. United Automobile Workers International Union v.
Johnson Controls,Inc., 1991) that "Decisions about the In many cases you can continue in your present job welfare 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 to the employers who hire those parents" (Reference 7).
reactor workers (approximately 93%) receive, in 12 The Supreme Court also ruled that your employer may months, occupational radiation doses that are less than not restrict you from a specific job "because of concerns
0.5 rem (5 mSv) (Ref. 11). The licensee may also con about the next generation." Thus, the lower limits ap sider the likelihood of increased radiation exposures ply only if you choose to declare your pregnancy in from accidents and abnormal events before making a writing.
decision to allow you to continue in your present job. 13. If I 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.
low you to continue performing your current job, for example, by having another qualified employee do a 14. What if I have a miscarriage or find out that I
am not pregnant?
small part of the job that accounts for some of your radi ation exposure. If you have declared your pregnancy in writing, you should promptly inform the licensee in writing that
9. What information must I provide in my written you are no longer pregnant. However, if you have not declaration of pregnancy? 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. How 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, If the declaration is not withdrawn, the written decla use a form letter the licensee has provided to you, or ration may be considered expired one year after write your own letter. submission.
8.13-5
16. If I have 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, Yes, you may. The choice is entirely yours. If you "The Rock and the Hard 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?" which is an article in the journal Radiation ProtectionManagement.
17. What if I work under contract at a licensed You may telephone the NRC Headquarters at (301)
facility?
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 at the following numbers: Region I, (610) 337-5000;
18. Where can I get additional information?
Region II, (404) 562-4400; Region III, (630) 829-9500;
The references to this Appendix contain helpful in 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.
8.13-6
REFERENCES FOR APPENDIX
1. National Council on Radiation Protection and 6. R. Doll and R. Wakeford, "Risk of Childhood Measurements, Limitation of Exposure to Ioniz Cancer from Fetal Irradiation," The BritishJour ing Radiation, NCRP Report No. 116, Bethesda, nal of Radiology, 70, 130-139, 1997.
MD, 1993.
7. David Wiedis, Donald E. Jose, and Timm 0.
2. International Commission on Radiological Phoebe, "The Rock and the Hard 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,orNursingChild,NCRP Commentary No.
index.html) 9, Bethesda, MD, 1994.
4. Committee on the Biological Effects of Ionizing 9. National Council on Radiation Protection and Radiations, National Research Council, Health Measurements, Risk Estimates for Radiation Effects of Exposure to Low Levels of Ionizing 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 RadiationDuringPreg fects of Atomic Radiation, Sources andEffects of nancy, National Radiological Protection Board, Ionizing Radiation, United Nations, New York, Chilton, Didcot, UK, 1998.
1993.
11. M.L. Thomas and D. Hagemeyer, "Occupational Radiation Exposure at Commercial Nuclear Pow er Reactors and Other Facilities, 1996," Twenty
'Single 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 USNRC, 1998.2 Reproduction and Distribution Services Section, OCIO, USNRC,
Washington, DC 20555-0001, or by fax to (301)415-2289, or by 2 email to <DISTRIBUTION@NRC.GOV>. Active guides may also 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 Technical Information 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 copyingfor 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 NRC Public Document Room at 2120 LStreet 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, Washington, DC
ton, DC 20555; telephone (202)634-3273: fax (202)634-3343. 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) I
(Date)
8.13-8
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
Fn ecycledg rl r Federal Recycling Program
UNITED STATES FIRST CLASS MAIL
POSTAGE AND FEES PAID
NUCLEAR REGULATORY COMMISSION USNRC
WASHINGTON, DC 20555-0001 PERMIT NO. G-67 OFFICIAL BUSINESS
PENALTY FOR PRIVATE USE, $300