United States
Environmental Protection
Office of
Radiation Programs
Washington, D.C. 20460
January 1987
Radiation  Protection
Guidance  to Federal
Agencies  for Occupational

Recommendations Approved
by the President

January 27, 1987
Part  II
The   President
Radiation Protection Guidance to Federal
Agencies for Occupational Exposure;
Approval of Environmental Protection
Agency Recommendations
  [This reprint incorporates corrections published in the
  Federal Registers of Friday, January 30, and Wednesday,
  February 4, 1987.]


Federal Register

Vol. 52, No. 17

Tuesday, January 27, 1987
Presidential Documents
Title 3—

The President
Recommendations Approved by the President

Radiation    Protection    Guidance    to    Federal    Agencies
for Occupational Exposure
                                The recommendations concerning Federal radiation protection guidance for
                                occupational exposure transmitted to me by the Administrator of the Environ-
                                mental Protection Agency in the memorandum published below are approved.
                                I direct that  this memorandum be published in the  Federal Register. To
                                promote a coordinated and effective Federal program  of worker protection,
                                the Administrator is directed to keep informed of Federal agency actions to
                                implement this guidance  and to interpret and clarify these recommendations
                                from time to time, as necessary, in coordination with affected Federal agen-
                                cies. Consistent with existing authority, the Administrator may, when appro-
                                priate, consult with the Federal Coordinating Council for Science, Engineering
                                and Technology. The Administrator may also, when appropriate, issue inter-
                                pretations and clarifications in the Federal Register.

                                Approved: January 20,1987
Billing code 3195-01-M
                                                                               \ O-aoyo^
                                Memorandum for the President

                                This memorandum transmits recommendations that would update previous
                                guidance to Federal agencies for the protection of workers exposed to ionizing
                                radiation. These recommendations were developed cooperatively by the Nu-
                                clear Regulatory Commission, the Occupational Safety and Health Adminis-
                                tration, the Mine Safety and Health Administration, the Department of De-
                                fense, the Department of Energy, the National Aeronautics and Space Admin-
                                istration, the Department of Commerce, the Department of Transportation, the
                                Department of Health and Human Services, and the Environmental Protection
                                Agency. In addition, the National Council on Radiation Protection and Meas-
                                urements (NCRP), the National Academy of Sciences (NAS), the Conference of
                                Radiation Control Program Directors (CRCPD) of the States, and the Health
                                Physics  Society were  consulted during the development of this guidance.

                                Executive Order 10831, the Atomic Energy Act, as amended, and Reorganiza-
                                tion Plan  No. 3 of 1970 charge the  Administrator  of the Environmental
                                Protection Agency (EPA) to ". . . advise the President with respect to radi-
                                ation matters, directly or indirectly affecting health, including guidance for all
                                Federal  agencies in the formulation of radiation standards and in the estab-
                                lishment and execution of programs of cooperation with States." This guid-
                                ance has historically taken the form of qualitative and quantitative "Federal
                                Radiation  Protection Guidance." The  recommendations transmitted here
                                would replace those portions of previous  Federal guidance (25 FR 4402),
                                approved by President Eisenhower on May 13, 1960, that apply to the protec-

Federal  Register / Vol. 52, No. 17 /  Tuesday, January 27, 1987 / Presidential Documents      2823

                       tion of workers exposed to ionizing radiation. The portions of that guidance
                       which apply to exposure of the general public would not be changed by these

                       These recommendations are based on consideration of (1) current scientific
                       understanding of effects on health from  ionizing radiation, (2) recommenda-
                       tions of international and national organizations involved in radiation protec-
                       tion, (3) proposed "Federal Radiation Protection Guidance for Occupational
                       Exposure" published on January 23,1981 (46 FR 7836) and public comments on
                       that  proposed guidance,  and  (4] the  collective experience of the Federal
                       agencies  in  the control of occupational exposure  to  ionizing radiation. A
                       summary of the considerations that led to these recommendations is provided
                       below. Public comments on the previously proposed guidance and a response
                       to those comments are contained in the document "Federal Radiation Protec-
                       tion  Guidance for Occupational Exposure—Response to Comments"  (EPA
                       520/1-84-011). Single copies of this report  are available from the Program
                       Management  Office (ANR-458), Office of Radiation Programs, U.S. Environ-
                       mental Protection Agency, Washington, D.C. 20460; telephone (202) 475-8388.


                       A review of current radiation protection  guidance for workers began in 1974
                       with the formation of a Federal interagency committee by EPA. As a result of
                       the  deliberations of that committee, EPA published an "Advance  Notice of
                       Proposed Recommendations  and Future  Public Hearings" on September 17,
                       1979 (44 FR 53785). On January 23, 1981, EPA published "Federal Radiation
                       Protection Guidance for  Occupational Exposures;  Proposed  Recommenda-
                       tions, Request for Written Comments, and Public  Hearings" (46  FR 7836).
                       Public hearings were held in Washington, D.C. (April 20-23, 1981); Houston,
                       Texas (May 1-2, 1981); Chicago, Illinois  (May 5-6, 1981), and San Francisco,
                       California (May 8-9, 1981) (46  FR 15205). The public comment period closed
                       July 6, 1981 (46 FR 26557). On  December 15, 1982, representatives of the ten
                       Federal agencies noted above, the CRCPD, and the NCRP convened under the
                       sponsorship of the EPA to review the issues raised in public comments and to
                       complete development of these recommendations. The issues were carefully
                       considered during a series of meetings,  and the conclusions  of the working
                       group have provided the basis for these recommendations for revised  Federal

                       EPA has  also sponsored or conducted four major studies in  support of this
                       review of occupational radiation protection guidance. First, the Committee on
                       the Biological Effects of Ionizing Radiations, National Academy of Sciences—
                       National Research Council reviewed the scientific data on health risks of low
                       levels of  ionizing  radiation in  a report transmitted  to EPA on July 22,  1980:
                       "The Effects on Populations of Exposure  to Low Levels of Ionizing Radiation:
                       1980," National Academy  Press, Washington, D.C.  1980. Second, EPA has
                       published  two  studies of occupational  radiation exposure:  "Occupational
                       Exposure to Ionizing Radiation in the United States: A Comprehensive  Sum-
                       mary for the Year 1975" (EPA  520/4-80-001) and "Occupational Exposure to
                       Ionizing Radiation in the United States: A Comprehensive Review for the Year
                       1980 and Summary of Trends for the Years 1960-1985" (EPA  520/1-84-005).
                       Third, the Agency sponsored a study  to examine the changes in previously
                       derived concentration limits for intake  of radionuclides from air or water that
                       result from use of up-to-date dosimetric and biological transport models.
                       These are presented in Federal Guidance Report No. 10, "The Radioactivity
                       Concentration Guides:  A New Calculation of Derived Limits for the 1960
                       Radiation  Protection Guides Reflecting Updated Models for  Dosimetry and
                       Biological  Transport" (EPA 520/1-84-010). Finally, the cost of implementing
                       the changes in Federal guidance proposed on  January 23, 1981 was surveyed
                       and the findings published in the two-volume report: "Analysis of Costs for
                       Compliance with  Federal  Radiation Protection  Guidance for Occupational
                       Exposure: Volume I—Cost of Compliance" (EPA 520/1-83-013-1) and "Volume
                       II—Case Study  Analysis of the Impacts" (EPA 520/1-83-013-2). These EPA

2824      Federal Register / Vol.  52, No. 17 / Tuesday, January 27, 1987 / Presidential Documents
                                 reports are available from National Technical Information Service, U.S. De-
                                 partment of Commerce, 5285 Port Royal Road,  Springfield, Virginia 22161.

                                 The interagency review of occupational radiation protection has confirmed the
                                 need for revising the previous Federal guidance, which was promulgated in
                                 1960. Since that time knowledge of the effects of ionizing radiation on humans
                                 has increased substantially.  We now  have  a greatly improved ability to
                                 estimate risk of harm due to irradiation of individual organs and tissues. As a
                                 result, some of the old numerical guides are now believed to be less and some
                                 more protective than formerly. Other risks, specifically those to the unborn,
                                 are now considered to be more significant and were not addressed by the old
                                 guidance. These disparities and omissions should be corrected. Drawing on
                                 this improved knowledge, the International Commission on Radiological  Pro-
                                 tection (ICRP) published, in 1977, new recommendations on radiation protec-
                                 tion philosophy and limits for occupational exposure. These recommendations
                                 are now in use, in whole or substantial part, in most other countries. We have
                                 considered these recommendations,  among  others,  and believe that  it is
                                 appropriate to adopt the general features of the  ICRP approach in  radiation
                                 protection guidance to Federal agencies for  occupational exposure.  In  two
                                 cases, protection of the unborn and the management of long-term exposure to
                                 internally deposited radioactivity, we have found it  advisable to  make addi-

                                 There are four types of possible effects  on health from exposure to ionizing
                                 radiation. The first of these  is cancer. Cancers caused by radiation are not
                                 different  from those that have been historically  observed, whether  from
                                 known or unknown causes. Although radiogenic cancers have been observed
                                 in humans  over  a range of higher doses, few useful data are available for
                                 defining the effect of doses  at normal occupational levels of exposure. The
                                 second type of effect is  the induction of hereditary effects in descendants of
                                 exposed persons. The severity of hereditary effects ranges from inconsequen-
                                 tial to  fatal. Although  such effects have  been observed in experimental
                                 animals at high doses,  they  have not been confirmed in studies  of humans.
                                 Based on extensive but incomplete scientific evidence, it is prudent to assume
                                 that at low levels of exposure the risk of incurring either cancer or hereditary
                                 effects  is linearly related  to the dose  received  in  the relevant  tissue.  The
                                 severity of any such effect is not related  to the amount of dose received. That
                                 is, once a cancer or an hereditary effect has been induced, its severity is
                                 independent of the dose. Thus,  for these two types  of effects, it  is assumed
                                 that there is no completely risk-free level of exposure.

                                 The third type includes  a variety of effects for which the  degree of damage
                                 (i.e., severity) appears  to  depend on the amount of dose received and for
                                 which there is an effective threshold below which clinically observable effects
                                 do not  occur. An example of such an effect is radiation sickness syndrome,
                                 which is observed at high doses and is fatal at very high doses. Examples of
                                 lesser effects include opacification of the lens of the eye, erythema of the skin,
                                 and temporary impairment of fertility. All of these effects occur at relatively
                                 high doses.  At the levels of  dose contemplated under  both the previous
                                 Federal guidance and these recommendations, clinically observable examples
                                 of this third type of effect are not known to occur.

                                 The fourth type includes effects on children who were exposed in utero. Not
                                 only  may the  unborn  be more sensitive than  adults to  the induction of
                                 malformations, cancer, and hereditary effects, but recent studies have drawn
                                 renewed attention to the risk of severe mental retardation from exposure of
                                 the unborn during certain periods of pregnancy. The risk of less severe mental
                                 retardation appears to  be  similarly elevated. Although it is not yet clear to
                                 what extent the frequency of retardation  is proportional to the amount of dose
                                 (the data  available at  occupational levels  of exposure  are limited),  it is
                                 prudent to assume that proportionality exists.

                                 The risks to health from exposure to low levels of ionizing  radiation were
                                 reviewed for EPA by the NAS in reports published in 1972 and in  1980.

Federal Register / Vol. 52. No. 17 / Tuesday.  January  27. 1987 / Presidential Documents     2825

                       Regarding cancer there continues to be divided opinion on how to interpolate
                       between the absence of radiation effects at zero dose and the observed effects
                       of radiation (mostly at high doses) to estimate the most probable effects of low
                       doses. Some scientists  believe that available data best support use of a linear
                       model for estimating such effects. Others, however, believe that other models,
                       which usually predict somewhat  lower risks, provide better estimates. These
                       differences of opinion have not  been resolved to date by studies of the effects
                       of radiation in humans, the most important of which are those of the Hiroshi-
                       ma and Nagasaki  atom bomb survivors. Studies are now  underway  to reas-
                       sess radiation dose calculations for these  survivors and  in  turn to  provide
                       improved estimates of risk.  It will be at  least several years  before these
                       reassessments and estimates are  completed, and it is not likely that they will
                       conclusively  resolve uncertainties  in  estimating low dose  effects.  EPA is
                       monitoring the  progress of this work. When it is completed  we will initiate
                       reviews of the risks of low levels of radiation, in order to provide the basis for
                       any indicated reassessment of this guidance.

                       In spite of the above uncertainties, estimates of the risks from exposure to low
                       levels  of ionizing  radiation are reasonably well bounded, and the  average
                       worker is believed to incur a relatively small risk of harm from radiation. This
                       situation has resulted from a system of protection which combines limits on
                       maximum dose with active application of measures to minimize doses within
                       these limits. These recommendations continue that approach. Approximately
                       1.3 million workers were employed in occupations in which they were poten-
                       tially exposed to radiation in 1980, the latest year for which we have compre-
                       hensive assessments. About half of these  workers received no measurable
                       occupational  dose. In that year the average worker measurably  exposed to
                       external radiation  received an occupational  dose equivalent of 0.2 rem to the
                       whole  body,  based on the readings  of individual  dosimeters  worn  on the
                       surface of the body. We estimate (assuming a linear non-threshold model) the
                       increased risk of premature death due to radiation-induced cancer for such a
                       dose is approximately  2 to 5  in 100,000 and that the increased risk of serious
                       hereditary  effects  is  somewhat  smaller. To  put these estimated risks  in
                       perspective with  other occupational  hazards, they are comparable to the
                       observed risk of job-related accidental death in the safest industries, whole-
                       sale  and retail  trades,  for which the annual accidental death rate averaged
                       about 5 per 100,000 from 1980 to 1984. The U.S. average for all industries was
                       11 per 100,000 in 1984 and 1985.

                       These recommendations are based on the assumption that risks of injury from
                       exposure to radiation should be considered in relation to  the overall benefit
                       derived from the activities causing the exposure.  This approach is similar to
                       that  used by the  Federal Radiation Council  (FRC) in developing the  1960
                       Federal guidance. The FRC said then,  "Fundamentally, setting basic radiation
                       protection standards involves passing judgment on the extent of the possible
                       health  hazard society is  willing to accept in order to realize  the  known
                       benefits of radiation." This leads to three basic principles that have governed
                       radiation protection of workers in recent decades in the United  States and in
                       most other countries. Although the precise formulation of these principles has
                       evolved over the years, their intent has continued unchanged. The first is that
                       any  activity involving occupational exposure should be determined to be
                       useful enough to society to warrant the exposure of workers; i.e., that a finding
                       be made that the activity is "justified". This same principle applies to virtually
                       any human endeavor which involves some risk of injury. The second is that,
                       for justified activities, exposure of the work force should be  as  low  as
                       reasonably achievable  (commonly designated by the acronym "ALARA"); this
                       has most recently been characterized as "optimization" of radiation protection
                       by the  International Commission on Radiological Protection (ICRP). Finally, to
                       provide an upper  limit on risk  to individual workers, "limitation" of the
                       maximum allowed individual dose is  required.  This  is required above and
                       beyond the protection provided by the first two  principles because  their
                       primary objective is to  minimize the total harm from occupational exposure in

2826      Federal Register /  Vol.  52, No. 17 / Tuesday,  January 27, 1987 / Presidential Documents
                                  the entire work force; they do not limit the way that harm is distributed among
                                  individual workers.

                                  The principle that activities causing occupational exposure  should produce a
                                  net benefit is important in radiation protection  even though the judgment of
                                  net benefit is not easily made. The 1960 guidance says: "There should not be
                                  any man-made radiation exposure  without the expectation of benefit resulting
                                  from such exposure . . ." And  "It is basic that  exposure to radiation should
                                  result from a real determination of its necessity." Advisory  bodies other than
                                  the FRC have used language which has essentially the same meaning. In its
                                  most recent revision of international guidance (1977) the ICRP  said ". . . no
                                  practice  shall  be  adopted unless  its  introduction produces a  positive net
                                  benefit," and in slightly different form the NCRP, in its most recent statement
                                  (1975) on this matter, said ". . .  all exposures should be kept to a practicable
                                  minimum; . . . this principle involves value judgments based upon perception
                                  of compensatory benefits commensurate with risks, preferably in the form of
                                  realistic numerical estimates of both benefits and risks from activities involv-
                                  ing radiation and alternative means to the  same benefits."

                                  This principle is set forth in these  recommendations in a simple form: "There
                                  should not be any occupational exposure of workers to  ionizing radiation
                                  without the expectation  of an  overall benefit from the activity causing the
                                  exposure."  An obvious difficulty in making this judgment is the difficulty of
                                  quantifying in  comparable terms costs (including risks) and benefits. Given
                                  this situation, informed value judgments are necessary and are usually all that
                                  is possible. It is perhaps useful  to observe, however, that throughout history
                                  individuals and societies have made risk-benefit judgments,  with their success
                                  usually depending upon the amount of accurate information available. Since
                                  more is known about radiation now than in previous decades, the prospect is
                                  that these judgments can now be better made  than before.

                                  The preceding discussion has implicitly focused  on major activities, i.e., those
                                  instituting or continuing  a general practice  involving radiation exposure of
                                  workers. This principle also applies to detailed  management of facilities and
                                  direct supervision of workers. Decisions  on  whether or not particular tasks
                                  should be carried out (such as inspecting control systems or acquiring specific
                                  experimental data) require  judgments  which can,  in  the  aggregate, be as
                                  significant for radiation protection  as those justifying the basic activities these
                                  tasks support.

                                  The principle of reduction of exposure to levels that are "as low as reasonably
                                  achievable" (ALARA) is typically implemented in two different ways. First, it
                                  is applied to the engineering design of facilities so as to reduce, prospectively,
                                  the anticipated exposure of workers. Second,  it is applied to  actual operations;
                                  that is, work practices are designed and carried  out to reduce the exposure of
                                  workers. Both of these applications are encompassed by these recommenda-
                                  tions.* The principle applies both to collective  exposures  of the work force
                                  and to  annual  and cumulative individual  exposures.  Its application may
                                  therefore require  complex judgments, particularly when tradeoffs  between
                                  collective and individual doses are involved. Effective implementation of the
                                  ALARA principle involves most of the many facets  of an effective radiation
                                  protection program: education  of workers  concerning the health  risks of
                                  exposure to radiation; training in regulatory  requirements and procedures to
                                  control exposure; monitoring, assessment, and  reporting of exposure levels
                                  and doses; and management and supervision  of radiation protection activities,
                                  including the choice and implementation of radiation  control measures. A
                                  comprehensive radiation protection program will also include, as appropriate,
                                    * The recomendation that Federal agencies, through their regulations, operational procedures
                                  and other appropriate means, maintain doses ALARA is not intended to express, and therefore
                                  should not be interpreted as expressing, a view whether the ALARA concept should constitute a
                                  duty of care in tort litigation. Implementation  of the  ALARA concept requires a complex,
                                  subjective balancing of scientific, economic and social factors generally resulting in the attain-
                                  ment of  average  dose levels  significantly below the maximum permitted by this guidance.

Federal Register / Vol. 52, No. 17 / Tuesday, January 27. 1987  / Presidential Documents      2827

                       properly trained and qualified  radiation protection personnel; adequately
                       designed, operated,  and maintained  facilities  and equipment; and  quality
                       assurance and audit procedures. Another important aspect of such programs is
                       maintenance of records of cumulative  exposures of workers and implementa-
                       tion of appropriate measures to assure that lifetime exposure of workers
                       repeatedly exposed near the limits is minimized.
                       The types of work and activity which involve worker exposure to radiation
                       vary greatly and are administered by many  different  Federal  and  State
                       agencies under  a wide  variety of legislative  authorities. In view  of this
                       complexity, Federal radiation protection guidance can address only the broad
                       prerequisites of an effective ALARA program, and regulatory authorities must
                       ensure that more detailed requirements are identified and carried out. In doing
                       this, such authorities may find it useful to establish or encourage the use of 1)
                       administrative control levels specifying,  for specific categories of workers or
                       work situations,  dose levels below the limiting numerical values recommend-
                       ed in this guidance; 2) reference levels  to indicate the need for such actions as
                       recording, investigation,  and intervention; and 3) local  goals for limiting
                       individual and collective occupational  exposures. Where the enforcement of a
                       general ALARA  requirement is not  practical  under an agency's statutory
                       authority, it is sufficient that an agency endorse and encourage ALARA, and
                       establish such regulations which result from ALARA findings as may be useful
                       and appropriate to meet the objectives  of this guidance.
                       The numerical radiation protection guidance which has  been in effect since
                       1960 for limiting  the maximum allowed dose to an individual worker is based
                       on the concept of limiting the dose to  the most  critically exposed part of the
                       body.  This  approach was appropriate,  given  the limitations of scientific
                       information  available at that time, and resulted in a set of five independent
                       numerical guides for maximum exposure of a) the whole body, head and trunk,
                       active blood-forming organs, gonads, and lens of eye; b) thyroid and skin of
                       the whole body;  c) hands and forearms, feet and ankles; d) bone, and e) other
                       organs. A consequence of this approach when  several different parts of the
                       body are exposed simultaneously is that only the part that receives the highest
                       dose relative to its respective guide is decisive for limiting the dose.
                       Current knowledge permits a more comprehensive approach  that takes into
                       account the separate contributions to the total risk from each exposed part of
                       the body. These recommendations incorporate the dose weighting  system
                       introduced for this purpose by the ICRP in 1977. That system assigns weighting
                       factors to the various parts of the body for the  risks  of lethal cancer and
                       serious prompt  genetic  effects (those in the  first two generations);  these
                       factors are chosen so that the sum of weighted dose equivalents represents a
                       risk  the same as that from  a numerically equal  dose equivalent to the whole
                       body. The ICRP recommends that the effective (i.e. weighted) dose equivalent
                       incurred in any year be limited to 5 rems. Based on the public response to the
                       similar proposal  published by EPA  in 1981 and Federal experience with
                       comparable exposure limits, the Federal agencies concur. These recommenda-
                       tions therefore replace the 1960 whole body numerical guides of 3 rems per
                       quarter and  5(N-18) rems cumulative  dose equivalent (where N is the age of
                       the worker)  and associated critical organ guides with a limiting  value of 5
                       rems effective dose equivalent incurred  in any  year. Supplementary limiting
                       values are also  recommended to provide protection against  those  health
                       effects for which an effective threshold is believed to exist.
                       In recommending a limiting value of 5 rems in any single year, EPA has had to
                       balance a number of considerations. Public comments confirmed that,  for
                       some beneficial  activities,  occasional doses aproaching this value are not
                       reasonably avoidable. On the other hand, continued annual exposures at or
                       near this level  over substantial portions  of a  working lifetime would, we
                       believe, lead to  unwarranted risks. For this reason such continued annual
                       exposures should be avoided, and these recommendations provide such guid-
                       ance. As noted  earlier,  these recommendations also  continue a system of
                       protection which combines limiting values for maximum  dose with a require-

2828      Federal Register / Vol.  52. No. 17 / Tuesday, January 27, 1987 / Presidential Documents
                                 ment for  active application of measures to minimize doses—the  ALARA
                                 requirement. This has resulted in steadily decreasing average annual doses to
                                 workers (most  recently to about one-fiftieth of the recommended  limiting
                                 value), and, to  date, only a few  hundred out of millions of workers have
                                 received planned cumulative doses  that are a  substantial fraction of the
                                 maximum previously permitted cumulative dose over an occupational  lifetime.
                                 EPA anticipates that the continued application of  the ALARA  requirement,
                                 combined with  new guidance on  avoidance of large cumulative doses, will
                                 result in maintaining risks to all workers at low levels. EPA will continue to
                                 review worker  doses with a  view to initiating recommendations  for any
                                 further modifications of the dose limitation system that are warranted by
                                 future trends in worker exposure.

                                 Certain radionuclides, if inhaled or ingested, may remain in and continue to
                                 irradiate the  body  for many  years. These  recommendations provide that
                                 radionuclides should be contained so as to minimize intake, to the extent
                                 reasonably achievable.  When avoidance of situations that may result in such
                                 intake  is not  practical, the recommendations distinguish  between pre-expo-
                                 sure and post-exposure situations. With respect to  the former, Federal agen-
                                 cies should base control of prospective internal exposure to radionuclides (e.g.
                                 facility design, monitoring, training, and operating procedures) upon the entire
                                 future dose that may result from  any intake (the committed dose),  not just
                                 upon the dose accrued in  the year of intake. This is to assure that,  prior to
                                 exposure to such materials, proper account is taken  of the risk due to  doses in
                                 future years.

                                 With respect to post-exposure situations, most significant internal exposure to
                                 radionuclides occurs as the result  of inadvertent intakes. In the case  of some
                                 long-lived radionuclides, it may also be difficult to measure  accurately the
                                 small quantities corresponding to the recommended numerical  guidance for
                                 control of committed doses. In such cases, when workers are inadvertently
                                 exposed or it is not otherwise possible to avoid intakes in excess  of these
                                 recommendations for control of committed dose,  it  will be necessary to take
                                 appropriate corrective action to assure control has been reestablished and to
                                 properly  manage  future  exposure of the worker.  In regard  to the  latter
                                 requirement, provision should be made to continue to monitor the annual dose
                                 received from radionuclides in the body as long as  they remain in sufficient
                                 amount to deliver doses significant compared to the limiting values for annual
                                 dose. These recommendations extend those of the ICRP,  because it is appro-
                                 priate to maintain active management of workers who exceed the guidance for
                                 committed  dose in  order that individual differences in retention  of such
                                 materials in the body be monitored, and to  assure, whenever possible, con-
                                 formance to the limiting values for  annual dose.

                                 These recommendations also incorporate guidance for limiting exposure of the
                                 unborn as a result of occupational exposure of female workers. It has long
                                 been suspected  that the embryo and fetus are more sensitive to a variety of
                                 effects of radiation than are adults. Although our knowledge remains incom-
                                 plete, it has now become clear that the unborn are especially subject  to the
                                 risk of mental retardation from exposure to radiation at a relatively early
                                 phase of fetal development. Available scientific evidence appears to  indicate
                                 that this sensitivity is  greatest during the period near the end of  the first
                                 trimester and the beginning of the second trimester of pregnancy, that  is, the
                                 period from 8 weeks to  about 15 weeks after conception. Accordingly, when a
                                 woman has declared her pregnancy, this guidance recommends not only that
                                 the total exposure of the unborn be more limited than that of adult workers,
                                 but  that the monthly rate of exposure be further limited in order to provide
                                 additional protection. Due to the incomplete state of knowledge of the transfer
                                 of radionuclides from the mother to the unborn (and the resulting uncertainty
                                 in dose to the unborn), in those few work situations where intake of  radionu-
                                 clides could normally  be possible it  may  also be necessary to  institute
                                 measures to avoid such intakes by pregnant women in order to  satisfy these

Federal Register  /  Vol. 52, No. 17 / Tuesday, January 27, 1987 / Presidential Documents      2829

                        The  health protection objectives of this guidance for the unborn should be
                        achieved in accordance  with the provisions of Title VII of the Civil Rights Act
                        of 1964, as amended, with respect to discrimination in employment practices.*
                        The  guidance applies only to  situations in which the worker has voluntarily
                        made her pregnancy known to her employer. Protection of the unborn may be
                        achieved through  such measures as  temporary job  rotation,  worker self-
                        selection, or use of protective equipment. The guidance recognizes that protec-
                        tion  of the  unborn  is  a  joint responsibility  of the employer  and  worker.
                        Workers should be informed of the risks involved and encouraged to voluntar-
                        ily make pregnancies known  as  early as possible  so  that any temporary
                        arrangements necessary to modify exposures can be made. Conversely, em-
                        ployers should make such arrangements  in a manner  that minimizes the
                        impact on the worker.

                        The recommended numerical guidance for limiting dose to workers applies  to
                        the sum of dose from external and internal sources  of radiation. This proce-
                        dure is recommended so  as to provide a single limit on the total risk from
                        radiation exposure. Therefore, in those cases where both kinds of radiation
                        sources are present, decisions about the control of dose from internal sources
                        should not be made without equal consideration of their implication for dose
                        from external sources.

                        The guidance emphasizes the importance of recordkeeping for  annual, com-
                        mitted, and cumulative  (lifetime)  doses. Such  recordkeeping should be de-
                        signed to avoid burdensome  requirements  for cases in which doses are
                        insignificant. Currently, regulatory records are not generally required for doses
                        small compared to regulatory limits for annual external  and internal doses.
                        Under this guidance such regulatory practices would continue to be appropri-
                        ate if due consideration is given to the implications  of summing internal and
                        external doses and to recordkeeping needs for assessing cumulative doses. To
                        the extent  reasonable  such records should be established on  the  basis  of
                        individual dosimetry rather than on monitoring of exposure conditions.

                        In summary,  many of  the important  changes  from the 1960 guidance are
                        structural. These include introduction of the concept of risk-based weighting
                        of doses to different parts of the body and the use of committed dose as the
                        primary basis for control  of internal exposure. The numerical values of the
                        guidance for maximum radiation doses  are also  modified. These changes bring
                        this guidance into  general conformance with international recommendations
                        and practice. In addition,  guidance is provided for protection of the unborn,
                        and increased emphasis is placed  on eliminating unjustified exposure and on
                        keeping justified exposure as low as reasonably achievable, both long-stand-
                        ing tenets of radiation protection. The guidance emphasizes the importance  of
                        instruction  of workers  and their  supervisors,  monitoring and  recording  of
                        doses to workers, and the use  of administrative control  and reference levels
                        for carrying out  ALARA  programs.

                        These  recommendations apply to workers exposed  to  other  than normal
                        background radiation on the job. It is sometimes hard to identify  such workers
                        because  everyone is exposed to natural sources  of radiation  and many
                        occupational  exposures are  small.  Workers or workplaces subject to this
                        guidance will be identified by  the responsible  implementing agencies. Agen-
                        cies will have to use care  in determining when exposure of workers  does not
                        need to be regulated. In  making such determinations agencies should consider
                          "The Civil Rights Act of 1964, as amended, provides that "It shall be an unlawful employment
                        practice for an employer (1) to fail or refuse to hire or to discharge any individual, or otherwise to
                        discriminate against any individual with respect to  his compensation, terms, conditions, or
                        privileges of employment, because of such individual's . . . sex ... or (2) to limit, segregate, or
                        classify his employees or applicants for employment in any way which would deprive or tend to
                        deprive any individual of employment opportunities or otherwise adversely affect his status as an
                        employee, because of such individual's .... sex ..."  [42 U.S.C. 2000e-2(a)]. The Pregnancy
                        Discrimination Act of 1978 defines "because of sex" to include  because of or on the  basis of
                        pregnancy, childbirth, or related medical conditions [42 U.S.C. 2000e(k)J.

2830      Federal Register / Vol. 52, No. 17  / Tuesday, January 27, 1987 / Presidential Documents
                                 both the collective dose which is likely to be avoided through regulation and
                                 the maximum individual doses possible.

                                 Implementation of these recommendations  will require changes  that  can
                                 reasonably be achieved only over a period of time. It is expected that Federal
                                 agencies will identify any problem areas and provide adequate flexibility and
                                 the necessary transition periods to avoid undue impacts, while at  the same
                                 time assuring reasonably prompt implementation of this new guidance.

                                 Upon implementing these recommendations, occupational exposure should be
                                 reduced. It is not possible to quantify the overall exposure reduction that will
                                 be realized because it cannot be predicted how efficiently these recommenda-
                                 tions will be implemented or how much of existing exposure is unnecessary.
                                 These  recommendations  reduce the maximum whole body dose that workers
                                 may receive in  any one year by more than half (i.e., from 3 rems per quarter to
                                 5 rems per year), require that necessary exposure to internal radioactivity be
                                 controlled on the basis of committed dose, require that internal and external
                                 doses  be  considered together rather than separately, and provide increased
                                 protection of the unborn. We also expect the strengthened and more explicit
                                 recommendations for maintaining  occupational exposure "as  low as reason-
                                 ably achievable" will improve the radiation protection  of workers. Finally,
                                 these recommendations would facilitate the practice of radiation protection by
                                 introducing  a self-consistent  system of limits in  accordance with that in
                                 practice internationally.


                                 The following recommendations are made  for the guidance  of Federal agen-
                                 cies in their conduct of programs for the protection of workers from ionizing

                                 1. There should  not be  any occupational exposure of  workers to ionizing
                                 radiation  without the expectation of an  overall benefit from the activity
                                 causing the  exposure. Such activities may be allowed provided exposure of
                                 workers is limited in accordance with these recommendations.

                                 2. No exposure is acceptable  without regard to the reason  for permitting it,
                                 and it  should be general practice  to maintain doses from radiation to levels
                                 below  the limiting values specified in these recommendations. Therefore, it is
                                 fundamental to  radiation protection that a sustained effort be made  to ensure
                                 that collective doses, as  well  as annual, committed, and cumulative lifetime
                                 individual doses, are maintained as  low as reasonably achievable (ALARA),
                                 economic and social factors being taken into account.

                                 3. In addition to  the above  recommendations, radiation  doses received as a
                                 result  of occupational exposure should not exceed the limiting values for
                                 assessed dose to individual workers specified below.  These are given sepa-
                                 rately for protection against different types of effects on health and apply to
                                 the  sum of doses from external and  internal  sources of radiation. For cancer
                                 and genetic effects, the limiting  value  is specified in  terms of a derived
                                 quantity  called the effective dose equivalent. For other health  effects, the
                                 limiting values  are specified  in terms  of  the  dose equivalent l to specific
                                 organs or tissues.
                                   1 "Dose equivalent" is the product of the absorbed dose, a quality factor which varies with the
                                 energy and  type of radiation, and other modifying factors,  as defined by  the  International
                                 Commission on Radiation Units and Measurements.

Federal Register / Vol. 52, No. 17 / Tuesday, January 27. 1987  /  Presidential Documents      2831

                        Cancer and Genetic Effects. The effective dose equivalent, HE, received in any
                        year by an adult worker should not exceed 5 rems (0.05 sievert).2 The effective
                        dose equivalent is defined as:
                         HE   *        WT HT  •

                         where WT is a weighting factor and HT is the annual dose equivalent averaged
                         over organ or tissue T. Values  of  WT and their corresponding organs and
                         tissues are:

                                               Gonads [[[  0.25
                                               Breasts [[[  0-15
                                               Red bone marrow [[[  0-12
                                               Lungs [[[  0-12
                                               Thyroid [[[  0-03
                                               Bone surfaces [[[  °-03
                                               Remainder3 ........................................... - .............................................  0.30

                         For  the  case  of uniform irradiation  of  the whole body,  where HT may be
                         assumed the same for each organ or tissue, the effective dose equivalent is
                         equal to the dose equivalent to the whole body.
                         Other Health Effects. In addition to the limitation on effective dose equivalent,
                         the dose equivalent,  HT, received  in any year by an adult worker should not
                         exceed 15 rems (0.15  sievert) to the lens of the eye, and 50 rems (0.5 sievert) to
                         any other organ,  tissue (including  the skin),  or  extremity4  of  the  body.

                         Additional limiting values which  apply  to the control  of dose from internal
                         exposure to radionuclides in  the workplace are specified in Recommendation
                         4. Continued  exposure of a  worker at or near  the limiting values for dose
                         received in any year  over substantial portions of a working lifetime should be
                         avoided. This should normally be accomplished through application of appro-
                         priate radiation  protection practices established under Recommendation 2.

                         4. As the primary means for controlling internal exposure to radionuclides,
                         agencies should require that radioactive materials be contained, to the extent
                         reasonably achievable, so as to minimize intake. In controlling internal  expo-
                         sure consideration should also be given to concomitant external exposure.

                         The control of necessary exposure of adult workers to radioactive materials in
                         the workplace should be designed,  operated, and monitored with  sufficient
                         frequency to ensure that, as the result of intake of radionuclides in a year, the
                         following limiting values for control of the workplace are satisfied: (a) the
                         anticipated magnitude  of the committed effective dose  equivalent from such
                         intake plus any annual effective dose equivalent from external exposure will
                         not exceed 5 rems (0.05 sievert), and (b) the anticipated magnitude of the
                         committed dose equivalent to any organ or tissue from such intake plus any
                         annual dose equivalent from external exposure will not exceed 50 rems  (0.5
                         sievert).  The  committed effective dose  equivalent from internal sources of
                         radiation, HE^o, is defined as:
                        "E,50  '   £  'T  «
                          2 The unit of dose equivalent in the system of special quantities for ionizing radiation currently
                        in use in the United States is the "rem." In the recently-adopted international system (SI) the unit

2832      Federal Register / Vol. 52,  No. 17 /  Tuesday, January 27,  1987  / Presidential Documents
                                  where  WT is defined as  in  Recommendation 3 and the committed dose
                                  equivalent, HT,5o, is the sum of all dose equivalents  to organ or tissue T that
                                  may accumulate over an individual's anticipated remaining lifetime (taken as
                                  50 years) from radionuclides that are retained in the body. These conditions
                                  on committed doses should  provide  the  primary basis for the control of
                                  internal exposure to radioactive materials.5
                                  In circumstances  where  assessment  of  actual  intake for  an individual
                                  worker shows the above conditions for control of intake have not been met,
                                  agencies should require that appropriate corrective action be taken to assure
                                  control has been reestablished  and that  future exposure  of  the worker is
                                  appropriately managed.  Provision  should be  made  to  assess annual dose
                                  equivalents due to radionuclides  retained in the body from such intake for as
                                  long as they are significant for ensuring conformance with the limiting values
                                  specified in Recommendation 3.
                                  5. Occupational dose  equivalents to individuals under the age of eighteen
                                  should be  limited to one-tenth of the values specified in Recommendations 3
                                  and 4 for adult workers.
                                  6. Exposure of  an  unborn child  should be less than that of adult  workers.
                                  Workers should be informed  of  currrent knowledge of  risks to  the unborn6
                                  from  radiation and of the responsibility of both employers and workers to
                                  minimize exposure  of the unborn. The dose equivalent to  an unborn as a result
                                  of occupational  exposure of a woman who has declared that she is  pregnant
                                  should be maintained as  low as reasonably achievable,  and  in any  case
                                  should not exceed  0.5 rem (0.005 sievert)  during the entire gestation  period.
                                  Efforts should be  made to avoid  substantial  variation above  the uniform
                                  monthly exposure  rate that would  satisfy this limiting value.  The limiting
                                  value for the unborn does not  create a basis for discrimination, and should be
                                  achieved in conformance with the provisions of Title VII of the Civil Rights Act
                                  of 1964, as amended,  regarding  discrimination in employment practices,  in-
                                  cluding hiring, discharge, compensation, and terms, conditions, or privileges of

                                  7. Individuals occupationally exposed to radiation and managers of  activities
                                  involving  radiation  should be instructed on  the basic  risks to  health from
                                  ionizing radiation and on basic radiation protection principles. This should, as
                                  a minimum, include instruction on the somatic (including in utero] and  genetic
                                  effects  of ionizing radiation, the  recommendations set forth in Federal radi-
                                  ation protection guidance  for occupational exposure and applicable  regula-
                                  tions  and  operating procedures which implement this guidance, the general
                                  levels  of risk and  appropriate radiation protection practices for their work
                                  situations,  and the  responsibilities of individual workers to avoid and mini-
                                  mize exposure.  The degree and  type  of instruction that is appropriate will
                                  depend on the potential radiation exposures involved.
                                  8. Appropriate monitoring of workers and the work place should be performed
                                  and records kept to ensure conformance  with these recommendations. The
                                  types and  accuracy of monitoring methods and procedures utilized should be
                                  periodically reviewed to assure that appropriate techniques are being  compe-
                                  tently applied.
                                  Maintenance of a cumulative record of lifetime occupational doses for each
                                  worker is  encouraged. For doses due to intake of radioactive materials, the
                                  committed effective dose equivalent and the quantity of each radionuclide in
                                  the body   should be assessed and recorded,  to  the extent practicable. A
                                  summary  of  annual, cumulative, and committed effective dose equivalents
                                  should  be  provided each  worker on no  less  than  an annual  basis; more
                                   5 When these  conditions on intake of radioactive materials have been satisfied,  it is not
                                 necessary to assess contributions from such intakes to annual doses in future years, and, as an
                                 operational  procedure, such doses  may  be assigned  to the year of intake for the purpose of
                                 assessing compliance with Recommendation 3.
                                   6 The term "unborn" is defined  to encompass the period commencing with conception and
                                 ending with birth.

Federal Register  /  Vol. 52, No. 17 / Tuesday, January  27, 1987 / Presidential Documents      2833

                        detailed information concerning his or her exposure should be made available
                        upon the worker's request.
                        9. Radiation exposure control measures should be designed, selected, utilized,
                        and maintained to ensure that  anticipated  and actual doses meet the  objec-
                        tives of this guidance. Establishment of administrative control levels7  below
                        the limiting values for control may be useful and appropriate for achieving this
                        objective. Reference levels8 may also be useful to determine the need to take
                        such actions as recording, investigation, and intervention. Since such admin-
                        istrative control and  reference levels  will  often involve ALARA  consider-
                        ations, they may be developed for  specific categories of workers  or work
                        situations.  Agencies should  encourage the establishment  of measures  by
                        which management can assess the effectiveness of ALARA efforts, including,
                        where appropriate,  local  goals  for limiting  individual and collective occupa-
                        tional doses. Supervision  should be provided on a part-time, full-time, or task-
                        by-task basis as necessary to maintain effective control over the exposure of
                        10. The numerical  values recommended herein should  not be deliberately
                        exceeded except  during  emergencies,  or under unusual circumstances  for
                        which the Federal  agency having jurisdiction has carefully considered  the
                        reasons for doing so in light of these recommendations. If Federal  agencies
                        authorize dose equivalents  greater  than these values for  unusual circum-
                        stances, they should make any generic procedures specifying conditions under
                        which such exposures may occur publicly available or make specific instances
                        in which such authorization has been given a matter of public record.

                        The following  notes are provided to clarify application of the above recom-
                       1. Occupational exposure of workers does not include  that due to normal
                       background radiation and exposure as a patient of practitioners of the healing
                       2. The  existing Federal guidance  (34 FR 576  and 36 FR 12921) for limiting
                       exposure of underground miners to radon decay products applies independ-
                       ently of, and is not changed by, these recommendations.
                       3. The  values  specified  by the International  Commission on  Radiological
                       Protection  (ICRP) for quality factors  and  dosimetric  conventions for  the
                       various types of radiation, the models for reference persons, and the results of
                       their dosimetric methods  and metabolic models may be used for determining
                       conformance to these recommendations.
                       4. "Annual  Limits  on Intake" (ALIs) and/or  "Derived Air Concentrations"
                       (DACs) may be used to limit radiation exposure from intake of or immersion
                       in radionuclides. The ALI or DAC for a single radionuclide is the maximum
                       intake in a year or average air concentration for a working year, respectively,
                       for a reference person that, in the absence of any external dose, satisfies  the
                       conditions on committed effective  dose equivalent and committed dose  equiv-
                       alent of Recommendation 4.  ALIs and  DACs may be derived  for  different
                       chemical or physical forms of radioactive materials.
                       5. The numerical values provided by these recommendations do not apply to
                       workers responsible for  the  management  of or  response  to  emergencies.
                       These recommendations  would replace those portions  of current Federal
                       Radiation Protection Guidance  (25 FR  4402) that apply to the protection of
                     •  workers from ionizing radiation. It is expected that individual Federal agen-
                       cies, on the basis of their knowledge of specific worker exposure situations,
                         7 Administrative control levels are requirements determined by a competent authority or the
                       management of an institution or facility. They are not primary limits, and may therefore be
                       exceeded, upon approval of competent authority or management, as situations dictate.
                         8 Reference levels are not limits, and may be expressed in terms of any useful parameter. They
                       are used to  determine a course of action, such as recording, investigation, or intervention, when
                       the value of a parameter exceeds, or is projected to exceed, the reference level.

2834     Federal Register / Vol. 52, No.  17 /  Tuesday, January 27, 1987 / Presidential Documents	

                                  will use  this new guidance as the basis upon which  to revise or develop
                                  detailed standards and regulations to the extent that they have regulatory or
                                  administrative jurisdiction. The Environmental Protection Agency  will keep
                                  informed of Federal agency actions to implement this guidance, and will issue
                                  any necessary clarifications and interpretations required to reflect new infor-
                                  mation, so as to promote the coordination necessary to achieve an effective
                                  Federal program of worker protection.

                                  If you approve the foregoing recommendations for the  guidance  of Federal
                                  agencies  in  the conduct  of their radiation protection activities,  I further
                                  recommend  that  this memorandum be  published in the Federal  Register.
                                                                                   Lee M.Thomas,
                                                                                   Administrator, Environmental
                                                                                   Protection Agency.
[FR Doc. 87-1716
Filed 1-22-87; 9:44 am]
Billing code 6560-50-M