United States Office of EPA 520/1-844)11
Environmental Protection Radiation Programs January 1986
Agency Washington, D.C. 20460
Radiation
&EPA Federal Radiation Protection
Guidance for Occupational
Exposure
Response to Comments
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RESPONSE TO COMMENTS
FEDERAL RADIATION PROTECTION GUIDANCE
FOR OCCUPATIONAL EXPOSURE
January 1986
Office of Radiation Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
EPA 520/1-84-011
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INTRODUCTION
The U.S. Environmental Protection Agency responds in this report to
comments received on proposed Federal radiation protection guidance for
occupational exposure (46 F.R. 7836, January 23, 1981). This guidance
was proposed to replace those portions of existing Federal guidance
(25 F.R. 4402, May 18, 1960) that apply to radiation protection of
workers. EPA Background Report No. 520/4-81-003 of January 16, 1981,
contains detailed information to supplement the text accompanying the EPA
proposal published as a Federal Register notice.
The Agency appreciates the interest and effort of all those who
submitted -comments. They provided an essential part of the information
and opinion that went into the formulation of. the final guidance.
We have attempted to include all of the substantive comments
received in. writing and in public hearings. They have been grouped into
three major sections and the topical categories and subcategories listed
in the Contents. In preparing this report, we generally found it
necessary to rephrase the language in order to combine similar comments
into single statements. We gave care, however, to preserve the essential
intent of each. A letter-number code (e.g., B.a-5) is used to identify
the type and name of each commenter. The letters in the code indicate
type of commenter: the first stands for one of six major categories
(e.g., B for industry) and the second one for the subcategory (e.g., "a"
for nuclear power) as shown on the Contents for Appendix A. The complete
code can be used to find the individual commenter's name and address in
that Appendix. The original documents are filed in EPA Docket No.
A-79-46- The large size of this file precluded our including
reproductions of these documents in this report.
The Agency's response follows each of the comments. We have made
every effort to be as candid and as objective as possible in these
responses, which reflect the information and judgments which resulted in
the final Federal guidance.
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CONTENTS
. Page
INTRODUCTION ........ . . i
SECTION'1.0.: General, Comments 1
1.1 Commendation, Agreement, and Support ' 1
1.2 Terminology, Clarity, and Accuracy 1
1.3 Adequacy of Existing Guidelines and Regulations -
Need for Change 4
1.4 Risk 7
1.5 Comparison of Radiation Risks with Other
Occupational Risks ...... 26
1.6 Consistency With and Validity of ICRP-26 28
1.7' Consistency with NCRP . . . . , 32
1.8' .Coordination with Other U.S. Agencies ........... 33
1.9 Economic Costs and Cost/Benefit 34
1.10 Recordkeeping 41
1.11 Miscellaneous - 42
SECTION 2.0 -- Specific Issues . . 51
2.1 Lower RPGs 51
2.2 Values of RPGs and RIFs Only Allowed to Decrease ...... 54
2.3 Transient Worker Issues and Adequacy of Occupational
Exposure Data Base 57
2.4 Omission of Medical and'Other
Non-Occupational Exposures 61
2.5 Omission of Underground Miners and
Other Occupational Categories 65
iii
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CONTENTS (Continued).
. Page
2.6 Omission .of Emergency Exposures 66
2.7 Impact of RPGs on Collective Dose 67
2.8 Consideration of Worker Age 69
2.9 Neglect of Procedures for Overexposures 70
2.10 Adequacy/Accuracy of Dose Measurement Technology 71
2.11 Engineering Controls/Design Limits 76
2.12 Quality arid Other Modifying Factors 77
2.13 Different Guides for Different Categories of Workers ... 78
2.14 Other Issues/Controversy 80
SECTION 3.0 -- Proposed Recommendations 85
"3.1 Justification 85
3.2 As Low As Reasonably Achievable (ALARA) 89
3.3 Radiation Protection Guides (RPGs) 94
. 3.3,1 Whole body, including 5(N-18) .'... 94
3.3.2 Gonads 99
3.3.3 Lens of eye. 100
3.3.4 Hands ........ 101
3.3,5 Any other organ 104
3.3.6 Weighting factors .... 105
3.3.7 50-year dose commitment 108
3.3,8 Combined internal and external doses 109
3.4 Minimum Radiation Protection Requirements 112
3.4.1 Overall Approach 112
3.4.2 Suggested Numerical Ranges . 115
3.4.3 Instruction 116
3.4.4 Monitoring and Recordkeeping 118
iv
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CONTENTS (Continued)
Page
3.4-. 5. Supervision .. ... .... .. . ... ... « 124
3:4.6. Lif etime: Dose . . ..'...''...... 126
3.5. ..Radioactivity ..Intake .Factors 129
3.6 Limits Below the Guides 133
3.7 Occupational Exposure of Minors 137
3.8 Exposure of the Unborn 138
3.9 Exceeding the RPGs . . . .153
REFERENCES. ^ ........... 159
. .APPENDIX A
«
COMMENTER IDENTIFICATION
A. Public
a. ..Individuals ........ V A-l
b. Universities A-6
c.. Public Interest Groups .... A-9
d. Professional/Scientific Organizations A-10
B. Industry
a. Nuclear Power .' A-14
b. Medical A-19
c. Others A-20
C. Unions A-23
D. State Government ...... A-24
E. Federal Government
a. Executive Agencies A-25
b. National Laboratories A-26
F. International . A-27
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SECTION 1.0 GENERAL COMMENTS
1.1 ... COMMENDATION, 'AGREEMENT, -AND SUPPORT
1.1.1.. The., proposed guidance to reduce health risks from radiation is
reasonable and supportable (A.a-18, A.a-36, A.b-22, A.b-25, A.C-7, A.d-15,
B.c-3,'0.1, E.a-7). ...
Response: We appreciate the comment and trust that the final guidance is
also reasonable and supportable.
1.1.2 The intent of the guidance to reduce the health risk associated
with exposure to ionizing radiation is a common goal (D-ll, E.a-2, E.b-3).
Response: No response required.
1.2 TERMINOLOGY, CLARITY, AND ACCURACY
1.2.1 . ''. The 'proposed guidance contains incorrect or insufficient
definitions, particularly those for "rem", "rad", "dose", "dose
equivalent", "occupational exposure", "radiation worker", "collective
dose", and "radioactivity concentration guide" .(A.a-5, A.a-12, A.a-23,
A.a-42, A.b-15, A.d-13, A.d-14, A.d-21, A.d-26, A.d-40). .
Response: In the proposed guidance, terms were explained in a manner
intended to be readily understood by the lay reader. The Agency was not
recommending that definitions of established technical terms (such as the
units of dose) be changed, and the final guidance continues that precedent.
1.2.2 The statement, is made on page 7837 of the Federal Register (Vol.
46) that "cancer is fatal at least half the time." Does EPA mean that
radiation induced cancer is fatal half the time, rather than all cancers
(A.d-14, A.d-22, A.d-40, B.c-20).
Response: The statement refers to all cancers, and infers that the same
is expected to be true of radiogenic cancers. See also the responses to
comments 1.4.40 and 1.4.41.
1.2.3 Both SI units and conventional units should be used with
conversion factors given for SI units (D.I, E.a-4).
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Response: The Agency did not use SI units because they have not been
officially adopted by the United States. However, this does not preclude
any of the Federal agencies' (or Agreement States) from, using SI units in
their regulations implementing new Federal guidance. The final
recommendations are expressed in conventional units with corresponding
values in .SI units .given.;iq parenthesis. ' . .
1.2..4, .Many items, in .this guidance are nebulous. For instance, should a
worker be punished with job loss for a "higher-than-normal" exposure
caused by the negligence .of the' licensee (A.a-5)?
Response: The preamble to the recommendations, the background document,
and the responses to comments all contain clarifications of the intent of
the guides. The example cited by the commenter is outside the scope of
Federal guidance. However, when regulations that implement Federal
guidance are not met, the appropriate action to be taken is the responsi-
bility of the cognizant regulatory agencies.
1.2.5. The term "justify" in recommendations 1 and 4 is unacceptably
vague (B.a-7, B.a-33, E.a-2, E.a-4, E.a-2).
Response: The Agency tried to avoid the use of vague terms in the final
recommendations. This particular term, however, is discussed in some
detail in the background report (EPA81),'and has an accepted meaning in
radiation protection, cf . ICRP-26 (Paragraphs 12, 68 and 69).
1.2.6 Disagreement with EPA by scientists will lead to a deterioration
of EPA's "scientific credibility" if it implements the recommendations
(A.d-25, A.d-35).
Response: There is ample evidence that scientists often disagree among
themselves, particularly on matters concerning radiation protection.
Adoption of ICRP-26 recommendations in the final recommendations is likely
to eliminate existing disagreement with some scientists, while giving rise
to new disagreement with others.
1.2-.7 EPA should use the adopted units of becquerel (Bq) and sievert
(Sv) (B.c-11).
Response: See the response to.comment 1.2.3.
1.2.8 Literature citations in the background report often do not provide
adequate support and justification for the guidance proposed (A.a-12,
A.a-14, A.a-23, A.d-14, A.d-22, A.d-40).
Response: In general, literature references in the background report
(EPA81) were used to identify the source of data and information cited in
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that report. Such data, and information were considered in making the value
judgments resulting in the proposed guidance. However, these value
judgments, were not necessarily already made in the cited references.
-1.2.9'1. The proposed guidance is .too.vague and difficult to follow (A.a-17',
A.a-19, A.d-40), . " .'
.Response:. ..We disagree. ..We.note that this proposed guidance is much more
explicit than the guidance it would replace, and that for 25 years
radiation protection authorities have generally succeeded in interpreting
that guidance.
1.2.10 "The background material for the proposed guidance omits several
data points, including: the magnitude of worker total exposure (external
plus internal) and its relationship to the 100 rem limit; magnitude of
internal exposure-; magnitude of forearm exposure; and the impacts of
lowering external limits (E.b-6).
Response: The external exposure of workers is covered in detail by the
report "Occupational Exposure to Ionizing Radiation in the United States:
A Comprehensive Review for the Year 1980 and a Summary of Trends for the
Years 1960-1985" (EPA-520/1-84-005) (Ku84). However, there is a paucity of
national or. international .data on. internal, exposures. What data are
available,- however, indicate that the magnitude of those exposures in
comparison to that of external exposures is small.
We have no data on external doses to the forearms, as such. We do
have some data, however, on annual doses to "extremities," normally taken
to be "hands and forearms." About half of those records showed no
measurable exposure while less than 0.1% of .them indicated exposures
greater than 30 rems. Final recommendations specify an annual limit of
50 rems for extremities (i.e., hands and forearms, feet and ankles).
Impacts of the recommended limits are covered in responses to
comments 1.9.1 through 1.9.18.
1.2.11 There is a clear need to monitor and regulate "non-nuclear" workers
in the medical profession (A.c~8).
Response: We would agree that there are workers in the medical profession
whose jobs may involve sufficient potential for exposure that they should
be monitored even though they may not be directly involved in the
administration of radiation to patients. Federal radiation protection
guidance for occupational exposure applies to all workers exposed on the
job. Regulatory agencies will incorporate the new Federal guidance, which
includes a recommendation on monitoring, into their regulations. Thus, all
workers who may be significantly exposed should be monitored and regulated
in accordance with these recommendations.
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1.2.12 EPA should stick to policy, not regulation (E.a-5).
Response: We agree. It is the responsibility of EPA to recommend the
basic policies and standards for radiation protection related to
occupational exposure; EPA does not regulate in this area.
1.3.- .'. . ADEQUACY-.OF .EXISTING GUIDELINES AND. REGULATIONS - NEED FOR CHANGE
1.3.1 The current limits are adequate. EPA has not demonstrated a need
for or benefits from any changes in the existing limits (A.a-6, A.a-11,
A.a-14, A.a-15, A.a-17, A.a-20, A.a-21, A.a-23, A.a-24, A.a-25, A.a-26,
A.a-27, A.a-28, A.a-29, A.a-30, A.a-31, A.a-32, A.a-33, A.a-34, A.a-35,
A.a-41, A.a-46, A.a-52, A.a-53, A.a-54, A.b-4, A.b-10, A.b-12, A.b-15,
A.b-16,-A.b-19, A.d-1, A.d-5, A.d-6, A.d-7, A.d-10, A.d-13, A.d-14,
A.d-16, A.d-18, A.d-19, A.d-21, A.d-22, A.d-25, A.d-26, A.d-28, A.d-29,
A.d-31, A.d-33', A.d-35, A.d-39, A.d-40, B.a-2, B.a-3, B,a-4, B.a-6, B.a-9,
B.a-11, B.a-12,. B'.a-13,'B.a-14, B.a-15, B.a-17, B.a-18, B.a-21, B.a-25,
B.a-27, B.a-28, B.a-29, B'.a-31, B.a-32, B.a-34, B.a-36, B.a-37, B.a-38,
B.a-39, B.a-44, B.a-47, B.a-48, B.a-54, B.b-6, B.b-7, B.b-22, B.c-9,
B.c-10,-B.c-12, B.c-13, B.c-14, B.c-16, B.c-18. B.c-20. B.c-22, B.c-23,
C-2., D-6, .E.a-2, E..a-3, E.a-5, E.b-3, E.b-4,. E.b-8). .
Response::' We do not agree. The interagency review of occupational .
radiation protection confirmed that it was the unanimous opinion of
Federal agencies that revision of existing Federal guidance, which was
promulgated in 1960, was long overdue. 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 to individual
organs and tissues from radiation. As a result, some of the old numerical
guides are now believed to be less, and some more, protective than
formerly. Other risks, particularly those to the unborn, are now
considered to be more significant, and were not addressed by the old
guidance. These disparities and omissions are corrected by the new
recommendations. The International Commission on Radiological Protection
(ICRP) published, in 1977, new recommendations on radiation protection .
philosophy and limits for occupational exposure. These new recommenda-
tions 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 additions.
The relatively large number of commenters who advocate making no
change perhaps reflect the adage that change is generally resisted. We
believe that the new recommendations.will result in improved radiation
protection for occupationally exposed workers.
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1.3.2 .The guidelines and supporting data require further analysis
(A.a-24, A.a-25, A.a-27, A.a-28, A.a-29, A.a-30, A.a-32, A.a-33, A.a-41,
A.a-52, A.a-53, A.a-54, A.d-21, A.d-25, A.d-29, B.a-25, B.a-37,. B.a-54,
B.b-6, B.c-13, B.c-18).
Response:- As proposed, the Agency has carefully .considered all oral and
written-comments in preparing its final recommendations. Additionally,
the'Agency'requested and-obtained' the advice of representatives of the
principal .Federal and State.agencies concerned, as well as of the National
Council -on Radiation Protection and Measurements and the Health Physics
Society.
1.3.3 Since EPA's proposed guidance is more stringent than that of
recognized national and international committees, the guidance should be
substantiated by an impartial review board (A.b-20).
Response: There is neither a statutory requirement nor an existing
institutional framework for such a review. The Agency itself serves the
.function of an impartial body, since it has neither a regulatory role for
occupational, exposure, nor is it. a user of radiation'. The proposed
'guidance was only marginally more stringent than the referenced
international and national private advisory bodies. In any case, the
issue is moot since the final recommendations are effectively the same as
those of-the ICRP, except for the recommendations addressing protection of
the unborn, which'incorporates the -same overall limit as that advocated by
the NCRP.. . . ' . . -
1.3.4 EPA should withdraw its proposed guidelines until input and
approval has been obtained from all Federal agencies (A.d-31).
Response: , EPA afforded opportunity for input from all affected Federal
agencies during the formulation of the proposed guidance, during the
public comment period, and during formulation of its final recommenda-
tions. There is no statutory requirement that EPA obtain "approval" from
Federal agencies prior to submitting its recommendations to the
President. Nevertheless, the Agency has requested and obtained
concurrence of the Federal agencies on these final recommendations.
1.3.5 The proposed guidance is based on the criterion that no limit
should be established at a value higher than experience shows is needed
(B.a-8).
Response: No response required.
1.3.6 The existing guidelines are inadequate and should be revised (C-6)
Response: We agree, and have done so.
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1.3.7 In some respects, the present RPGs appear to be too restrictive.
Operational experience would not suggest unwarranted exposures to large
'numbers of workers (NUREG-0463, NUREG-0594, DOE/EV/007271) (E.b-4).
Response: We do not agree that present guides may be too restrictive just
because few .workers exceed the .guides. The explicit Intent.of the guides
is that no worker, should, exceed them. .
1.3.8 EPA should immediately lower exposure limits by a factor of 10 to
50:(A.a-7): .
Response: It is true that many occupational tasks can be carried out
under lower exposure limits; however, some cannot. This is indicated by
our studies of occupational exposure in 1975 (CobSO) and 1980 (Ku84) and
by some comments (see the response to comment 2.1.9). For this reason the
final guidance, provides for such lower limits to be established as
administrative control levels. See also the response to comment 2.1.9.
1.3'.9 EPA-'s proposal does not. go far enough; consideration should be
given to engineering and personnel protection, rather than administrative
controls (D-ll).
Response: We agree that administrative controls alone are not sufficient,
and that engineering safeguards and personnel-protective measures and
devices are essential for properly protecting workers._ 'They receive
explicit mention in those parts of the guidance that concern keeping
exposures ALARA. Their application, however, does not obviate the need
for administrative controls.
1.3.10 The goal should be elimination of radiation- exposure (A.a-5).
Response: We agree in the sense that a goal of automobile safety is the
elimination of traffic deaths. However, the analogous goals of
eliminating radiation exposure and traffic deaths are realized in a way
that does not foreclose the benefits of using radiation and automobiles.
In the same sense that the extremes of zero and unlimited speed limits are
not acceptable, so also are we led to accept some range of risks in
activities using radiation rather than forego desirable benefits. Thus,
we seek the elimination of unjustified and unnecessary exposure while
providing an upper limit on the maximum risk to individual workers through
radiation protection standards.
1.3.11 The major thrust of new guidelines should be further education
(A.d-19).
Response: We agree that adequate instruction of radiation workers and
their managers is essential, and such a provision is included in the
recommendations.
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1.3.12 If exposure limits are changed, workers' confidence in their level
of health protection.would erode (A.d-39, B.a-21).
Response: We recognize the possibility of this occurring. However, the
converse is also true.. That is, if knowledge of risks changes and the
limits do not reflect, this, confidence would, also erode. -This is one .
reason for instructing workers and persons concerned with worker
protection on the health basis for the recommendations.
1.3.13 EPA is dragging its feet in establishing new exposure guidelines
(A.a-5).
Response: Admittedly, it has taken a long time for the Agency to
recommend new guidance. However, from the very early stages (1974) of the
review of existing guidance, it was apparent that there was no need for
any drastic, or immediate changes to existing Federal radiation protection
guidance for occupational exposure. This permitted the Agency to carry
put studies.and to consult.with affected Agencies.
1.3.14 The existing limits are not being abused, yet there is sufficient
latitudes to allow exposures up to 3 rems a quarter if the need arises.
You have assumed that there is a significant amount of unjustified
exposure, but the, small percentage of workers with exposure over 5 rems
per'year does not support that premise (B.a-21).
Response:' EPA did not assume or imply that there was a significant amount
of unjustified exposure above 5 rems per year. In any case, any need to
allow exposures up to 3 rems is not precluded by the new recommendation of
5 rems per year.
1.4 RISK
1.4.1 EPA risk estimates are based upon the linear dose-response model
set forth in the 1972 BEIR (BEIR-I) report, and ignore the 1980 BEIR
(BEIR-III) report which suggests that a linear-quadratic model is more
appropriate, resulting in reduced risk estimates (A.a-18, A.a-19, A.a-31,
A.a-38, A.a-40, A.b-1, A.b-3, A.b-17. A.d-9, A.d-14, A.d-16, A.d-21,
A.d-25, A.d-31, B.a-1, B.a-12, B.a-18, B.a-21, B.a-29, B.a-30, B.a-44,
B.a-24, B.c-12, B.c-20, B.c-22, E.a-7).
j
Response: The risk estimates for occupational exposure that were
published in the background report (EPA81) were prepared before the 1980
BEIR-III report, "The Effects on Populations of Exposure to Low Levels of
Ionizing Radiation: 1980" of the National Academy of Sciences (NAS), was
published (NAS80). The Agency has now updated these estimates. In doing
so, we have used the age-dependent risk coefficients for a linear response
given in the BEIR-III report. Our use of the BEIR-III report for risk
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estimates is described in the document, "Radionuclides - Background
Information Document for Final Rules - Volume I," EPA 520/1-84-022-1
(EPA84a), in'which the Agency's choices between the various models
proposed by the BEIR-III Committee are examined in more detail than
outlined in this response to comments.
To.-allow for'an/assumed lesser response at low doses and dose
rates, the 1980 NAS BEIR Committee based its "preferred risk estimates" on
a' hypothetical.linear-quadratic.dose response function. The Committee made
this choice after examining, analytically, the cancer mortality data (and
particularly..the leukemia mortality data) for A-bomb survivors on the basis
of three dose response functions: linear, linear-quadratic and quadratic.
The Agency believes only the first two of these functions are compatible
with data on human cancer. A quadratic response function has been shown to
be inconsistent with the observed excess risk of solid cancers at Nagasaki,
where the estimated T65 gamma-ray doses are not seriously confounded by an
assumed neutron dose component. The chance that a quadratic response
function underlies the excess observed in the Nagasaki incidence data for
solid cancers is only one in ten thousand (Wab83).
Although a quadratic response function is not incompatible with
the observed leukemia incidence at Nagasaki, Beebe and others (Be78, E177)
have pointed out how unrepresentative the Nagasaki Life Span Study Sample
on leukemia is, in comparison to the observed dose response for total
leukemia experience in that. city. Moreover, even for the total A-bomb
Survivor Life Span 'Sample there is no evidence that a quadratic response
function, provides a better fit to the observed'leukemia excess than a
simple linear model (NAS80). The Agency does not believe a quadratic
response can be used in a serious effort to estimate cancer risks due to
ionizing radiation.
... .Althoughthe majority of the members on the BEIR-III Committee
"preferred".a linear-quadratic response in 1980, we believe the
quantitative basis for this judgment is considerably weaker now because of
the subsequent reassessment of the A-bomb dosimetry. The Committee's
analysis of dose response functions assumes that most of the observed
excess leukemia (and solid cancer) among A-bomb survivors was due to
neutrons (NAS80). Current evidence, however, is conclusive that neutrons
were a minor component of the dose in both Hiroshima and Nagasaki (Bob82,
RERF83, RERF84). Therefore, it is likely that the linear response
observed among the A-bomb survivors, which the BEIR Committee largely
attributed to neutrons was, in fact, due to their gamma dose, not a dose
of high LET radiation (EPA84a)..
Although there is evidence for a nonlinear response to low-LET
radiations in some, but not all, studies of animal radiocarcinogenesis,
the Agency is not aware of any data on human cancers that is incompatible
with a simple linear model. In such a case, we believe it is preferable
to adopt the simplest hypothesis that adequately models the observed
radiation effect. Occams' razor is still a viable scientific rule for
separating necessary from ad hoc assumptions. Moreover, EPA believes that
risk estimates for the purpose of assessing radiation impacts on public
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'health should be based on scientifically credible risk models that are not
likely to understate the risk. Given the current bias in the doses
assigned to A-bomb survivors, such an approach seems particularly
reasonable, as well as prudent. Therefore, the estimates of the risks of
radiogenic cancer presented below are based on an assumed linear response.
- .. : The Agency also does not assume that only doses above some
.unspecified threshold level can start the chain of molecular events that
'lead to. cancer-and hereditary .defects. We note that neither the
International Commission on Radiological Protection (ICRP) nor the
National Council on Radiation Protection and Measurements (NCRP) have
adopted a nonlinear dose response function or a threshold hypothesis as
the basis for recommending limits to avoid stochastic damage due to
occupationally-incurred exposures. While retaining a linear response
function, both groups have, however, either explicitly or implicitly
assumed that the carcinogenic effects of radiation are, like radiogenetic
effects, reduced at low dose rates. In particular, NCRP Committee 40 has
suggested that the carcinogenic effects of low-dose and low-dose-rate
exposure to .low-LET radiations may be a factor of 2 to 10 times less than
that observed at.high doses (NCRP80).
The- low-dose, low-dose-rate effectiveness factors developed by
NCRP Committee 40 are based on their analysis of a large body of plant and
animal.data that showed reduced effects at low doses for a number of end-
points,/.including . (to a lesser extent) radiogenic cancer in animals,
chiefly rodents. However,"no human data confirm these findings. A few
human studies contradict them. Highly fractionated small doses to human
breast tissue are apparently as carcinogenic as large acute doses (NAS80,
LaaSO). Furthermore, small acute doses (less then 10 rad) to the thyroid
are as effective per rad as much larger doses in initiating thyroid cancer
(UN77, NAS80). Moreover, the increased breast cancer due to chronic low
dose occupational gamma ray .exposures among British dial painters is
comparable to, or larger than, that expected on the basis of acute high
dose exposures (Ba81). .While none of .these examples are persuasive by
themselves, collectively they indicate that it may not be cautious to
estimate cancer risks due'to low doses and low dose rates on the basis of
an assumed reduced effectiveness of low doses compared to observations at
large doses.
The Agency notes that the ICRP risk estimates for cancer assume a
dose rate effectiveness factor of 2.5. Moreover, cancer risk estimates
for occupational exposure based on the BEIR-III linear quadratic model are
2.4 times smaller than those based on their linear model. Except for
breast cancer, it is possible that a linear model does overestimate the
risk due to low-dose-rate low-LET exposures. If so, estimates based on
the BEIR-III linear model would be conservative. However, the Agency has
reservations concerning the adequacy of BEIR-III linear-quadratic risk
estimates, due to the errors in the dose estimates the Committee used for
the A-bomb survivors (EPA84a) and its assumptions regarding the transfer-
ability of animal data to humans. Selection of the Committee's linear
response estimates minimizes these sources of bias in the BEIR-III
Committee's risk estimates.
-------
Risk estimates for fatal cancer based on, the 1980 and 1972 BEIR
reports are compared in Table 1. These estimates assume exposure at 'a
dose rate of 5 rad per year of low-LET radiation from age 18 to 65 (U.S.
Life Tables: 1969-71, NCHS75). They were obtained using a life table
methodology to account for age dependence of risk, and to correct for the
.effect'of competing-.causes .of death (Bu81). A .linear, response is. assumed
in both sets of calculations. Following BEIR-III, the expression period
for'leukemia is assumed to be 25 years, after a minimum induction period
(mip) of two years... After.a ten year mip, a balance of lifetime
expression period is assumed for solid cancers (NAS80). Risk estimates
that assume that radiocarcinogenesis is reduced by a factor of 2.5 at low
dose rates (or an equivalently model, such as the BEIR-III linear
quadratic dose response function) would be 40% of those listed in Table. 1.
Table 1. Estimated probability of fatal cancer due to continuous
exposure to low-LET radiation at 5 rad per year from age 18 to 65
Relative Risk). 0.06A 0.027
'a)Absolute risk used for leukemia and bpne cancer; all other cancers
based on relative risk.
(b)Average for both sexes
For comparison, .the balance-of-lifetime probability of cancer in U.S.
males and females at age 20 was 0.17 and 0.16, respectively, in the year
1970. From Table 1, it is seen that risk estimates for male- workers based
on the NAS BEIR-III estimates are quite comparable to those provided
(average for both sexes, only) in the 1972 NAS BEIR-I report; while for
women, the newer risk estimates are somewhat larger.
Table 1 refers to cancer mortality, not cancer incidence. Al-
though some have argued that cancer incidence is a better indicator of
cancer risk than is fatal cancer .(NAS80), the Agency has continued to use
cancer fatality as its index of radiogenic risk for several reasons. The
mortality data for radiogenic cancer is more extensive than that for
incidence. (This may change fairly soon when the Hiroshima A-bomb survivor
cancer incidence data is published.) A second reason is that comparisons
of risk between industries should be made using a common end point.
Mortality estimates meet this criterion. Comparisons between the number
of industrial accidents and the total number of radiogenic cancers are not
10
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meaningful. Comparisons based on days of employment lost may be better,
but are still not a true measure of impact. It should be noted, however,
that the estimated total number of cancers due to occupational exposure is
considerably greater than the estimated number of fatal cancers. Incidence
is estimated as being about 54% greater than mortality for males and 100%
greater for females in NAS8Q. The-difference between the sexes is largely
due t;o .the much higher incidence of radiogenic thyroid cancer (20%
mortality) and breast cancer (39% mortality) in females (NAS80).
1.4.2' From the large.variety of studies on radiation-induced cancer,
the best current dose-response relationship for cancer risk is described
by a shallow linear component at low levels and a curvilinear or quadratic
component at intermediate and high levels (B.a-40).
Response: The linear-quadratic response risk coefficients in the NAS
BEIR-III lead to risk estimates for occupational exposure that are smaller
by a factor of about 2.5 than those shown in Table 1 (see comment 1.4.1.)
It is possible that at low doses (and low dose rates) the induction of
some forms of human cancer is reduced. However, the only human cancer for
which there is enough data to test this hypothesis, breast cancer,
indicates that any quadratic component in the dose response is negligible
and in fact may be negative (Lac83). Examination of cancer incidence for
all solid cancers at Nagasaki leads to a similar conclusion (Wab83).
The -Agency does not know of any human data on radiogenic cancer "
at low doses' that is appreciably more consistent with a linear-quadratic
dose response function than with a simple linear response-function. Some
data sets, such as that for the radium dial painters, do show a quadratic
component at extremely high doses. In contrast, other studies, such as
the one on U.S. uranium miners, show a reduced effect per unit dose in the
high dose- range.. However, these perturbations occur at doses too large to
be of regulatory concern for occupational exposure. The Agency
acknowledges that the precise shape of the dose response function for
chronic exposure in the normal range of occupational exposure is unknown.
In this range of exposure, both the linear and linear quadratic hypotheses
assume no threshold and a proportional response between dose and effect.
The difference between the calculated risks using these two models, about
a factor of 2.5, is smaller than the uncertainty as to what the risk
actually is. See also the responses to comments 1.4.1 and 1.4.25.
1.4.3 In the region from natural background radiation rates to the
occupational annual limit of 5 rem/yr, the overall cancer mortality risk
is in the range of lxlO~5 to 5xlO~5 per rem (B.a-40).
Response: The above estimate of mortality risk appears to be derived on
the basis of the 10 lifetime risk estimate for occupational exposure
.described in ICRP Publication 26 and the Dose Rate Effectiveness Factor
(DREF) discussed in NCRP Report No. 64. This NCRP Committee said "The
effectiveness per unit dose of high vs. low dose-rate exposure ranges from
11
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a factor of about 2 to about 10. However, it is incorrect to apply the
NCRP. DREF to the ICRP Publication 26 risk estimate, since this risk
estimate already includes a .dose rate reduction factor of 2.5, based on
the limited analysis of leukemia mortality among A-bomb survivors
presented in UN77. -See also the response to comment 1.4.1 and the
'document, referenced as.EpA84a. . . . . . ..
1.4;4 Use-of the. BEIR-III dose-response relationship, rather than the
EPA risk model", results 'in a risk from occupational exposure to radiation
which is .a factor of 1.-5 to 2.2 times lower than the EPA estimates, and is
a more appropriate risk model than that used by EPA (A.b-17. B.a-30).
Response: The actual difference between the BEIR-III linear and
linear-quadratic models is a factor of 2.5. See the responses to comments
1.4.1 and 1.4.2.
1.4.5 The linear hypothesis probably overstates the risk by a factor of
two to ten for low doses and low dose rates (B.a-13, B.a-30).
Response: This comment apparently refers, by implication at least, to
conclusions reached in NCRP Report No. 64. This report is considered in
the response to comment 1.4.1.
.1.4.6:'. The linear, .nonthreshold dose-re'sponse hypothesis is merely a
theory, and*should not be used as the basis for. setting lower occupational
exposure limits (A.a-12, A.d-40).
Response: The ICRP, the NCRP, and the United Nations Scientific Committee
on the Effects of Atomic Radiation, as well as EPA, estimate radiation
risks based on this hypothesis. Moreover, we know of no human data that
seriously conflicts with the linear, nonthreshold hypothesis. It is a
prudent hypothesis for evaluating radiation risks.
The Agency does not believe use of a. linear, nonthreshold
response function to evaluate ra'diation risks is unduly conservative. The
late Dr. Walter Snyder, a respected senior radiation protection scientist
at the Oak Ridge National Laboratory, summarized the case for linearity
many years ago in testimony before the Joint Committee on Atomic Energy:
"Those who prefer to base radiation protection on a threshold hypothesis,
which is just as unproven and just as uncertain and unsupported by data as
is the linear hypothesis, often charge the linear hypothesis is too
conservative. There is no evidence...that it is conservative at all.
However, one may wonder why it is considered so undesirable to use a
conservative criterion where human life is in question. Surely if the
linear hypothesis is conservative and is not in conflict with the data
that are available, this is a point in its favor. When human life Is in
the balance, it would seem that conservatism in safeguarding these lives
has much to commend it." (Sn67).
12
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1.4.7 EPA's estimate of an increased risk of 3 to 6 in 100 of dying
from occupational exposure to radiation at the 'maximum hypothetical
lifetime limit of 235 rems is based on conservative assumptions and is
likely to be an overestimate (E.a-5).
Response:. We have tried to be reasonably, conservative in .our choice
of a dose.response function. (See responses to comments 1.4.1, 1.4.2,
and'l.'4.6, above.')' However, given the current uncertainties in risk
estimation, .the likelihood that risks due to radiation have been either
overestimated or, less likely, underestimated cannot be established.
Current data supports the use of a relative risk model, indicating the
maximum occupational risks may be nearer the higher estimate than the
lower one (Ka82, Jaa83).
1.4.8 Risk estimates based on linear extrapolation from high doses do
not provide realistic estimates of actual risks from low-level, low-LET
radiations (A.a-13, A.d-13, E.a-5).
Response: See the responses to comments 1.4.1, 1.4.2 and 1.4.7.
1.4.9 . The 1980 BEIR report, as well as other published studies,
were not able to demonstrate effects at the level of current limits
Response: Current' limits were set with the expectation that any increase
in detrimental health effects due to allowed exposures would be so" small
as to be hidden by normal biological variations (ICRP64, NCRP71). We
agree that, in this regard, current guidance and the use of the ALARA
principal have been successful. Nevertheless, excess breast cancer has
been observed among occupationally exposed workers (Ba81). Although the
Agency hopes the result of this study is not confirmed by studies of other
exposed .groups, we do not believe it is in the public interest to be
sanguine on .this point.
1.4.10- There are no demonstrated somatic or genetic effects at low
levels of radiation (A.a-17, C-2).
Response: If by low levels of radiation one means dose rates comparable
to background radiation, 0.1 rad per year, this statement is true.
Dose-response models are used to interpolate between the lowest exposures
at which excess cancer has been observed and exposure levels due to
background. This is reasonable, since there is no reason, a priori, to
conclude that risk is zero even when it cannot be demonstrated
statistically. It is unlikely that a study of a large enough group of
animals or persons can be mounted to irrevocably answer this question.
However, the data on excess cancer due to _in_ utero exposure indicate that
single doses as low as a few hundred mrem may cause cancer (St73, Ha75)
13
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and occupational exposures of a few rems per year are likely to be the
cause of increased breast cancer (see the response, to comment'1.4.9). The
Agency believes it is likely that some radiation risk does accrue from
even very low levels of exposure.
.1.4.11 There 'is no evidence to indicate that biological risk factors are
any higher than they were considered to be when current guidelines were
promulgated- (A.d-31). ......'.....
Response: .The comment does not reflect what was known about risk factors
when the current guidelines were promulgated in 1960. This was well
before any numerical risk estimates for radiogenic cancer became
available. The first comprehensive and quantitative discussion of
radiation risks, those of the NAS-BEIR Committee, was published in 1972.
The first explicit risk estimates by the Federal Radiation Council were
made in their 1962 report on health implications from fallout.
1.4.12 In'its risk estimates, EPA should correct surface doses to mean
whole-body dose, which- would result-in lower risk estimates by at least a
factor of two (A.b-17, A.d-22).
Response: Like the.NAS BEIR-III Committee, the Agency uses organ doses,
not surface doses,.as the basis for its risk estimates. It is true that
occupatioTial exposures are often regulated in terms of the dose measured
at or near, the body surface. Depending on how penetrating the radiation
is, the dose to body organs may be quite comparable or iti' some situations,
such as for diagnostic radiation and deep organs, substantially less.
This is a problem related to implementing the Federal Guidance, not risk
estimation. We see no merit in specifying a "mean whole-body dose". A
weighting-system that considers the difference in the radiosensitivity of
various organs as proposed in ICRP 26 and adopted in this guidance is
preferable.
1.4.13 . EPA's risk-estimating methodology is flawed because one-half of
the calculated cancers occur past the average life expectancy; also, the
dose received later in life is less likely to have a genetic effect
(A.a-12).
Response: The comment is'not correct; the Agency's risk-estimating
methodology does not contain such flaws. In 1978, the Agency developed a
life-table methodology for cancer risk estimation to avoid the problem
cited in this comment (Coa78, Bu81) It has subsequently been adopted by
other Federal agencies and was used by the BEIR committee to prepare their
1980 report. The EPA lifetable analysis accounts for exposure, minimum
induction period, and the period of expression across a full life span, as
well as for all of the competing risks leading to other causes of death
(Bu81).
14
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Our genetic risk estimates are based on accumulated dose to age
30, which is the midpoint of reproductive activity. The total genetic
risk, including that.due to doses received past age 30, is then estimated
from the mean accumulated dose at age 30 to the gonads of persons having
children. . '
1.4.14 There -is ho scientific support for the' assumption that all
radiation.exposure is harmful (B.a-54). Indirect evidence suggests that
there''is a threshold -value of radiation below which it is harmless (A.c-6).
Response: Most radiation scientists, including all of those on the
NAS/BEIR-III Committee, support the use of a nonthreshold hypothesis for
estimating the likelihood of radiation-induced cancer and hereditary
effects. The Agency follows the criterion for the use of risk estimates
outlined in 1972 BEIR report (p. 96); "If the intent of authorities is to
minimize the loss of life that radiation exposure may entail, they must,
indeed, be guided by such estimates, and will not rely on notions of a
threshold." While .the lack of a threshold is unprovable experimentally,
we know of no indirect evidence for a threshold for radiogenic cancer or
hereditary effects. See also the. responses to comments .1.4.6, 1.4.9, and
1.4.10. '' . ' ;
1..4,.15 EPA does not consider the mounting evidence that at low levels,
'radiation may everi.be beneficial (A.a-31, A.a-46, A.d-35, B.c-22).
Response: The Agency is familiar with reports 'of the beneficial effects
of radiation, often referred to as -radiation hormesis. The hermetic
action of radiation, and a number of other nonspecific hermetic stimuli,
is usually seen in an animal population reared under sub-optimal
conditions i.e.,. a. high intercurrent infectious disease level. However,
there is no demonstrated hormetic affect on tumor induction or the aging
process. Hence, the risk of premature death due to radiation induced
cancer presented, in. the Background Report would be unchanged by
consideration of hormesis. This conclusion is largely based on the
discussion of radiation-induced hormesis presented in "Handbook of the
Biology of Aging" (Saa77).
1.4.16 There are no nonstochastic effects at an exposure level of 15
rem/yr, and the stochastic effects are independent of dose rate (A.a-41).
Response: The purpose of nonstochastic limits is to prevent the
occurrence of impairment due to a large amount of cellular damage by
limiting the rate at which radiation injury occurs. It is presumed that
at low dose rates cellular repair prevents any manifestation of
nonstochastic effects.
Not all stochastic effects are dose rate independent. For
example, genetic injury is believed to be dose rate dependent at exposure
rates greater than 0.8 R/min [NAS80, p.107]. As noted in the response to
15
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comment 1.4.1, the Agency agrees that it is prudent to assume that the
probability of inducing fatal cancer is likely to be independent of dose
rate.
r.4.17' The'linearity .assumption for genetic.effects is erroneous,
because dose"rate exerts, a significant influence on the hereditary effects
of a given radiation dose (B.a-42).
Response: The variation in genetic response with dose rate does not
confound the linear dose -response relationship at low dose rates (BEIR-III
p.113). The Agency agrees that for low-LET radiations, genetic risks are
somewhat less for chronic than for acute exposures. This has been taken
into account in the Agency's estimates of genetic damage (EPA81, EPA84a).
However, there is a limit to how much genetic risks are reduced at low
dose rates. Dose rate effects for genetic risk estimations have not been
noted at exposure rates less than 0.8 R/min [NAS80, p.107]. Few
occupational exposures are expected to occur at higher dose rates.
It should be noted that the genetic risk estimates published in
the background teport (EPA81) may be underestimates. The genetic risk
.estimates were based on the 1972 BEIR report which assumed the sensitivity
of the oocyte was near zero. The BEIR-III committee assumed the female
(oocyte) was about 40% as sensitive as the male (NAS80). More recent
studies have reparted that the .male and female are equal in sensitivity
(Doa83, Dob84). See the documents,referenced as EPA84a for a more
complete discussion of current EPA genetic risk estimates. See also the
response to comment 3.8.51.
1.4.18 It is a prudent and conservative approach, for regulatory
purposes, to assume a linear, nonthreshold dose-response model (B.a-38,
B.a-40, B.a-41).
Response: The Agency agrees.
1.4.19 EPA does not call attention to the weaknesses of the 1980 BEIR
report, and in particular, its failure to note the biases in the
supporting data (A.b-25). BEIR-III's numbers are not firm and they don't
really allow you to set firm guidelines for safety (A.d-25, A.b-4).
Response: Strengths and limitations of the 1980 BEIR-III report are
described in EPA84a and in the response to comment 1.4.1 above. The
Agency believes it is the best available source of information, but that
it must be interpreted carefully in terms of more recent information (see
the response to comment 1.4.1 and reference EPA84a).
1.4.20 Based on the work of Bross, Mancuso, Morgan, and Rotblat, the
'risk factors are higher than those derived from the Japanese studies;
therefore, the linear hypothesis is nonconservative (A.a-4, A.c-6, C-6)
16
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Response: While a "supra-linear" dose response for low-LET radiations at
low dose and dose rates has been postulated by some, almost no
quantitative data have been presented. The hypotheses proposed by Bross,,
Mancuso, Morgan, and .Rotblat have not been corroborated by other
'investigators. The cited studies are often based on preliminary data,
unknown or- incomplete exposure data, confounding with chemical and
industrial'carcinogen exposure, short follow-up, etc. The Agency is
familiar with these works as well as those which contradict them. The
linear, ..nonthreshold hypothesis still appears to be the prudent approach
to use in assessing the maximum risks permitted by radiation protection
standards.
1.4.21 Exposure at EPA's proposed limits for bronchial and female breast
tissues would at least triple the lifetime risk of lung cancer for
nonsmokers, and almost double the lifetime risk of breast cancer
(A.a-38). The doses of low level radiation currently permitted by NRG
standards cause at least a doubling of the risks of leukemia, lung cancer
and other fatal and nonfatal diseases (A.a-4).
Response: The Agency believes consideration of the estimated fatality due
to all radiogenic cancers, as shown in Table 1at comment 1.4.1, is a
better indicator of occupational risks than the potential increase of any
particular cancer. If a radiogenic cancer is of a type common in the U.S.
.population, the percentage increase due to radiation is smaller than for a
relatively'rare cancer; yet the numerical impact is larger. -For example,
the Agency;has calculated breast cancer mortality for a "dose of 5 rems per
year for age 18 to age 65. (An annual dose to the breast that exceeds the
whole-body dose limit is unrealistic.) The results of a life-table
analysis using the data in tables A-4 and V-15 of NAS80 are shown in Table
2 below. These indicate that the estimated increase of fatal breast
cancer due to. the.unrealis.tically high assumption of a lifetime exposure
at 5 rads per year is 50 to 80%.
The comment concerning the probability of lung cancer due to
occupational exposure appears to assume the Agency's risk estimates for
the entire population may be applied directly to smokers and nonsmokers
considered separately. As there is yet insufficient data on radiogenic
lung cancer to calculate separate risk coefficients for smokers and
nonsmokers, the risk coefficients used in NAS80 and those used by EPA are
average values for smokers and nonsmokers combined. Moreover, they are
based on mortality data for males. Table 2 compares the ambient risk of
lung cancer among U.S. males with the increased risk due to 5 rems per
year from age 18 to 65 (U.S. Life Tables: 1969.-71, NCHS75). At this dose
rate, the risk of radiogenic lung cancer is appreciably smaller than the
normal risk for the U.S. male population as a whole. For leukemia, the
increased probability of induction by the maximum allowed occupational
exposure compared to normal incidence is much greater than for radiogenic
breast or lung cancer, see Table 2. Because of these differences between
cancer types, the Agency believes the estimated total of all fatal cancers
(See Table 1 in the response to comment 1.4.1.) is the best index of
increased cancer mortality.
17
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Table 2. Lifetime probability of fatal cancer due to continuous
exposure giving 5 rems per year from age 18 to age 65
. . ..'-.. -Increase in Normal Lifetime
Cancer . . . Lifetime Probability Probability at age 20
'''. . ''''.' (5"rems' per year) (no- occupational dose)
Breast (female)
Lung Cancer (male)
Leukemia (male)
Leukemia (female)
All Cancer^) (male)
All Cancer^) (female)
0.024U)
______
_____
0.066(a)
0.09l(a)
o.oiew
0.014(b)
0.01l(b>
0.0085Cb)
0.035(b)
0.050(b)
0.03
0.052
0.0066
0.0060
0.17
0.16
(a)Based' on a relative risk projection and a linear dose response model.
(b)Based on .an- absolute risk-projection and a linear dose response model.
(°)Including leukemia.
1.4.22 ; Because"of new evidence concerning dosimetry to be applied to
dose-response results for the Hiroshima A-bomb survivors, EPA's risk
estimates must be recognized as too low (A.a-38). New guidelines should
be delayed until the questions regarding the Hiroshima-Nagasaki dosimetry
are resolved (A.a-19, A.b-16, A.d-14, A.d.-22, A.d-27, A.d-33, E.a-4).
Response: In view, of the current uncertainty concerning the doses to
individual A-bomb survivors, we believe it is premature to categorize our
risk estimates as either too low or too high. While the neutron doses (in
air) from the Hiroshima weapon were probably much smaller than assumed in
the 1980 BEIR report and other contemporary analyses, new estimates of
organ doses due to gamma radiation are somewhat larger for unshielded
survivors (RERF 83, 84). Final resolution of this question will depend on
the doses to individual survivors, most of whom were not in the open, but
shielded. We do not expect, however, that large changes will occur in
risk estimates. In any event, EPA risk estimates will be re-evaluated as
riew data becomes available and are conservative to the extent- that they
are based on an assumed linear nonthreshold response, rather then the
linear quadratic dose response proposed in the 1980 BEIR report.
1.4.23 The potential impact of the revised Hiroshima dose estimates does
not justify any delay in the development of new radiation guidance or
regulations (E.a-6). The reexamination of the Hiroshima data is not
expected to significantly alter current dose-effect estimates (A.d-13).
18
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Response: The Agency concurs to the extent outlined in the response to
comment 1.4.22..
1.4.24 The existing data base relating to. risk is adequate for judgments
relating to.radiation guidelines (B.a-40). . . .
Response: 'The Agency agrees to the extent outlined in the response to
comment 1.4.22.
1.4.25 Direct observations of human populations under 20 rad are not
going to improve the risk estimates (B.a-41).
Response: Whether this is true or not depends on the size of the
population under observation and how frequently cancers of a particular
type are observed in an unexposed population (see LaaSO, LabSO).
Nevertheless, compatibility of observations at less than 20 rads with
those at higher levels are of interest even if they have low statistical
significance. This 'is because they still can provide information on the
shape of the dose response curve. For example, breast cancer incidence
among the Atomic Bomb survivors at doses less than 20. rad (low-LET) is
compatible with a linear projection of the incidence observed at much high
doses. This sets a. limit on how much the response at high dose might be
increased-by a. dose squared response. It is anticipated that longer
follow-up ..-periods, will clarify this result for other radiogenic cancers. -
1.4.26 The time has come to answer the question of health effects at
occupational levels of exposure based on observed scientific data, rather
than on estimates, assumptions, and hypotheses (A.a-4, A.a-13). No one
has. been identifiably injured by ionizing radiation while working within
the existing standards (B.a-1).
Response: The absence of observed excess cancer in most occupationally
exposed groups is evidence that current regulations and health physics
practices are sufficient to keep the detriment due to radiation below
uncertainties due to normal variation in nonradiogenic cancer introduced
by sampling variation and normal population variability. However, the
experience of the early radium dial painters illustrates that estimating
risk on the basis of observation at higher doses and modeling assumptions
is a small price to pay compared to the ultimate cost inherent in basing
radiation protection limits on a requirement that detriment be observed
before establishing adequate protection. See also the response to comment
1.4.10.
1.4.27 Animal data from inbred strains, although not used for absolute
values of risk, provide information vital to our understanding of
radiation effects (A.d-22).
19
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Response: Animal data can provide insights into possible carcinogenic
processes. However, in view of the heterogeneity of all human
populations, we believe considerable caution must be exercised when
drawing conclusions from observations on irradiated animals - particularly
inbred strains of laboratory animals. Results of animal studies must also
be.-examined carefully to determine if . comparable physiologic and . metabolic
systems occur so that .results can be extrapolated to man in a rational
way. It is often difficult to interpolate between- different strains of
even the same species .for similar insults.
Extrapolation to other species requires very considerable caution
and qualification, particularly when large differences in life span are
involved. Those who perform animal studies are usually careful to
indicate that the comparatively large risks per unit dose observed in some
studies should not be applied to estimates of human risk. Yet they
generally fail to present evidence that such increased sensitivity is
unrelated to other physiological parameters that affect interspecies
comparisons. For example, inbred species which are much more prone to
radiogenic cancer than humans often show a quadratic response beginning at
.100 rad or so (NCRP80). No evidence has been published indicating why a
quadratic response in the- less radiosensitive 'human species would a_ priori
begin at a comparable dose level.
1.4.28. The Bross.reanalyzes of the Tri-State study adult leukemia data
are.flawed' by an erroneous statistical analysis, -a correct version of-
which,leads to results which are so statistically indeterminate as to be
meaningless (B.a-41). .
Response: The Agency did not base estimates of occupational,radiation
risks on the study referred to above. See also the response to comment
1.4.20. ..-.
1.4.29 Since we have no way of preselecting the individuals most
susceptible to radiation effects, limits set to protect these individuals
will be set unrealistically low for the majority of workers (A.d-31). The
thesis of significant variation in radiosensitivity used in EPA's
background report is not supported by any quantifiable data, and in any
case, hypersensitivity should not be used as a factor in risk estimation
of large populations (A.b-17).
Response: The recommended level was not chosen based on estimates of risk
to highly susceptible individuals. Nevertheless, it is useful to recall
the heterogeneity of human populations when drawing conclusions from the
shape of the dose response function observed in studies with animals (see
the response to comment 1.4.22). The purpose of the discussion in the
Background Report (pp. 43-44) was to highlight the uncertainty of using
data from inbred animal strains. It also points to the possible lack of
conservatism for estimating the risk to particular individuals using the
linear dose response models. To the extent that a portion of an exposed
20
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population is significantly more sensitive to .radiation than the average,
a linear response function does not provide an estimate of upper limit of
the risk. However, observations on exposed human populations to date,
which presumably are a cross section of the human condition, are
compatible-with.a linear response function (Wab83).
1.4.30 We do" not know that the range of sensitivity of individuals is as
extreme as that quoted in EPA's background document (A.d-22).
Response:- The discussion of the possible consequences of population
heterogeneity in the background document is illustrative, not
quantitative. (See also the response to comment 1.4.29).
1.4.31 It would seem prudent to avoid occupational exposure in the
radiation-sensitive subpopulation rather than lower the maximum
permissible exposure (B.a-52).
.Response: Adequate techniques to identify sensitive or unique
subpopulations-have not been developed. (See also the response to comment
1.4.30)..
1.4.32 EPA should consider in its risk estimates the genetic as well as
the somatic'risk (A.a-3). " '
. - * .
Response: EPA's assessment included consideration of genetic risk.
1.4.33 Genetic damage and mutations may well be the greatest risk of
all; yet we have very little.info-rmation. in .this area (C-8).
Response: While the Agency agrees that the amount of information on
genetic risk is limited, based on BEIR III analyses (NAS80), it doubts
that the hereditary risk exceeds that of.radiation induced cancer.
Extensive study of the offspring of Japanese A-bomb survivors fail to show
any statistically significant increase in genetic effects (Sc81, Sab82),
while excess cancer is clearly evident in the survivors themselves (Ka82,
Wab83). See also the response .to comment 3.8.51.
1.4.34 Limits for workers which deal with genetic risk.should deal with
all generations, rather than just the first two generations (C-8).
Response: EPA estimates of hereditary risks include two cases: the first
generation, and the 1st generation plus all succeeding generations (EPA8.1,
EPA84a). We have considered both immediate and long term hereditary
damage, recognizing that estimates of future risks are based on indirect
evidence on the prevalence of recessive mutations and how long they will
be maintained.
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1.4.35 Any radiation exposure limit which adequately protects the worker
against the risk of cancer will automatically protect the population
against hereditary effects, because risks of the latter are significantly
smaller than'risks of' the former (B.a-42).
Response: While the. Agency agree.3 that genetic risks are probably less
than-somatic risks, it does not'believe they should be ignored. In the
final .recommendations, the risk of hereditary damage is included in the
calculation of- the effective dose equivalent limit.
1.4.36 There is no evidence to support EPA's contention that the oocytes
in the female fetus are more sensitive to radiation-caused mutations than
are those of adult women (B.a-42).
Response: Information in BEIR III (Note 9. Oocyte Sensitivity, p. 110)
shows the relationship is more complex than originally thought (EPA81).
There is now evidence of species-specific differences in oocyte killing
and mutation sensitivity. However, BEIR III indicated there is still
uncertainty as to which stage of mouse oocyte development is similar to .
the immature arrested human oocyte.' While it may be conservative to
consider fetal oocytes more sensitive than immature arrested adult
oocytes, such prudence is not unreasonable in light of what is currently
known.- See also the response to comment 3.8.51.
1.4.37 The relative role of radiation risk is significantly distorted,
given the very high risk of cancer from other causes (A.a-41, A.d-13,
B.a-31, B.c-12).
Response: The relative probabilities of fatal cancer due to occupational
exposure and due to ot.her causes was not a basis for, these recommendations
1.4.38 Based on the 1980 BEIR report and a linear quadratic dose
response function, the additional cancer deaths projected over a lifetime
due to lifetime occupational exposure in nuclear power plants at the
collective dose rate occurring in 1979 are 1.2 to 2.0 percent of the
deaths from all forms of cancer, depending on the risk projection model
used, absolute or relative risk. If the linear dose response model from
the 1972 BEIR report is used, these values would rise by a factor of only
2 to 3 (A.a-42).
Response: The Agency agrees and notes that if the commenter had based his
estimates on the linear dose response estimates in the 1980 BEIR report,
his estimate of absolute risk would be about 1.5 times larger than
absolute risk estimates based on the 1972 BEIR report. In contrast,
relative risk estimates have remained about the same for exposure of
adults. This is because additional cancers have continued to occur in
exposed groups at about the same rate as in nonradiogenic cancer in these
aging populations, in accordance with the basic assumption underlying the
relative risk model.
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1.4.39 EPA should consider in its risk estimates the incidence of
nonfatal as well as fatal cancers (A.a-38, D-ll).
Response: Data on the incidence of radiogenic cancer is very limited
in comparison with mortality data for excess cancer due to radiation.
Nevertheless,, we estimated that incidence exceeded mortality by about
a factor of: two (NAS80,. EPA81, EPA84a),-and considered this ratio in
proposing these recommendations. Information on excess cancer incidence
"among- irradiated A-bomb survivors at Hiroshima is now being analyzed
by the Radiation Effects Research Foundation. When these data are
published, along'with:new estimates'of the doses to individual survivors,
it then may be possible to make more acute estimates of the increased
risk of cancer incidence due to radiation. See also the response to
comment 1.4.1.
1.4.40 The estimate that 50% of cancers are fatal is not supported by
U.S. death statistics (A.d-22, B.a-26).
Response: Death statistics do not provide information on the incidence of
nonfatal'cancer. The background report discussed various ways of
estimating the ratio of incidence to mortality; none are exact. Table
V-15, page 200 in the.1980 BEIR report indicates a ratio of 2 for females
and 1.54 for males. In our 1981 "Background Report", page 41, we
ast.imated this ratio as. between'2.0 and 1.5 -(average for both sexes).
Reconsidering this question in 1955, the Agency has-concluded that
incidence cannot be estimated with any more accuracy now, but it may be
possible to do so. in the foreseeable future. See also the response to
comment 1.4.39.
1.4.41 EPA states that cancer is fatal "at least" half the time; this
should have been stated "at most half of the time," since it is not
expected to rise from its current value (A.b-1).
Response: Based on information available at this time, half or more o'f
all cancers combined is fatal. We do not know whether this will increase
or decrease in the future. See the response to comment 1.4.40.
1.4.42 The use of measures of life-reduction provides better perspective
than the use of average early fatalities when comparing various types of
risks (B.a-30).
Response: A number of perspectives are useful when comparing different
kinds of risk. Along with the average years of life lost to affected
individuals, we have also included lifetime risk and the average years of
life lost in the population as whole. We think all of these measures
should be available for judging the hazards associated with exposure to
radiation.
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1.4.43 The weight of evidence appears to favor the absolute over the
relative risk model (A.d-13);
Response: We disagree. The appropriate model for projecting future risk
varies with the specific cancer being considered. "An absolute risk
projection mo.del appears to. be appropriate only for- leukemia-, and,
possibly, for bone cancer. For all solid cancers a relative risk model
agrees'much better with epidemi'ological observations (Ka82, Jaa83). The
observational evidence, is that.absolute risks increase with the duration
of" foliow-up, regardless of the age'at exposure, while the relative risk
remains fairly constant (Ka82, Wab83) We note that these results are
unlikely to be very' dependent on the results of the ongoing dose
reassessment for A-bomb survivors.
1.4.44 A combination of a threshold system of setting exposure limits
with a risk-based system is unappealing (A.d-22).
Response: Some types of radiation injury are nonstochastic, that is, both
the likelihood and severity of response changes with dose, and may exhibit
a' threshold. .Other injuries' are stochastic, that is, the probability of
their occurrence increases with increasing dose without exhibiting any
.threshold, and their severity is independent of dose. While it may be
unappealing, each type of radiation injury must be considered and
.controlled on-a basis- that is appropriate to the characteristics of its
relation 'to dose'. '
1.4.45 At occupational levels of exposure, the quantification of risks
are so highly uncertain that the balancing of risks and benefits is not
useful to pursue (A.a-13).
Response: We do not agree. Reasonable estimates can be made of the
impact of various levels of radiation exposure on those occupationally
exposed. It is more often the benefits of the radiation exposure which
are difficult to quantify. However, we believe both estimates are
necessary to informed decision making.
1.4.46 With the assumption of uniform whole-body exposure the difference
of 1.6% in life expectancy is presumptive and impossible to detect
(A.d-21).
Response: We agree that it is unlikely, that a 1.6% difference in life
expectancy could be accurately assessed in any practical follow-up study
of the occupationally exposed. It is not clear, however, what relevance
this observation has to the establishment of radiation protection limits.
1.4.47 Fanned-by the media, the public's perception of radiation risks
is .grossly distorted from the actual facts (B.a-35, B.a-39).
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Response: The purpose of the documents supporting this guidance is to
attempt to provide factual material to assist the public in its evaluation
of radiation risks.
Iv4.48 .The radiation worker should be .allowed to decide whether or not
to accept the risks associated with radiation (A.a-31, A.a-36, A.a-41,
A.d-19, B.a-54). '
Response: This observation can be made (and has been) for all industrial
hazards. However, the Government has an overall duty to its citizens to
limit the hazards of the workplace in a reasonable manner, since economic
pressures could otherwise force unwise decisions by individuals.
1.4.49 The excess population dose due to living in Colorado (200,000
person-rem/yr) is about five times the collective occupational dose
attributable to the nuclear power industry in 1979 (40,000 person-rem/yr),
yet no one is recommending evacuation or restriction of growth in Colorado
(B.a-39).. '
Response: The above-cited excess collective dose for Colorado residents
(2,890,000 persons in 1980) is in error. The correct value is about
106,000 person-rem/yr above average U.S. background exposure. Residents
of Colorado .'are .not., exposed annually to incremental background terrestrial
and cosmic radiation anywhere near the. current mean annual occupational
exposure to nuclear power workers. The average dose equivalent from
background cosmic and terrestrial radiation for the entire U.S. population
is 53.4 mrem compared to a low of 40.4 mrem in Florida and a high of 90.1
mrem in Colorado (Boa81). Thus, the mean incremental, risk to Colorado
residents from such background radiation (an average increment of less
than 40 mrem/yr above the.U.S. average) is much lower than that for
nuclear power workers (650 mrem/yr) (Ku84).
1.4.50 There is real concern that the reduction in occupational exposure
limits for nuclear medicine workers will have the effect of increasing
risks to patients (A.d-21).
Response: While this concern was expressed occasionally by medical
practitioners at public hearings on the proposed recommendations, all
agreed that risks at their own institutions would not be increased.
Rather, the concern was for other institutions which had less
sophisticated radiation protection programs. If this guidance encourages
better radiation protection at such institutions, it will have fulfilled
one of its purposes. We believe this can and will be done without any
increase in patient risks.
1.4.51 The full range of risk given by the 1980 BEIR Report (BEIR-III)
should be used in lieu of the risk quoted from BEIR-I (A.d-22).
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Response: The delay in publication of the BEIR-III Report, coupled with
ensuing uncertainties concerning this report, precluded its detailed
treatment in the background report. The Agency, however, did determine
that the risk information in BEIR-III was not inconsistent with the BEIR-I
risk estimates. In formulating the final guidance we have included
assessments of .risk.based on applicable results from BEIR-III. See also
the responses to comments 1.4.1 and 1.4.2.
1.5 -COMPARISON OF RADIATION RISKS WITH OTHER OCCUPATIONAL RISKS
1.5.1 Radiation risks to nuclear power workers are not higher than the
risks experienced by workers in non-nuclear industries (A.d-21, B.a-31,
B.a-34).
Response: We agree in general. The estimated average lifetime risk of
premature death for nuclear power workers exposed to 650 mrem annual dose
(i..e. 0.3-0.8%) is comparable to the average lifetime risk of accidental
death for all industry workers (i.e. 0.5%) (NSC84), assuming a working
lifetime of 47 years. However, see the response to comment 1.5.4 for
further detail of accidental death risks to specific worker groups and for
discussion of comparability of accidental and cancer deaths.
1.5.2 EPA should consider the value of radiation use in its.judgment
concerning acceptable occupational risk (A.d-14).
Response: This consideration is covered by the first recommendation.
1.5.3 The comparison of the risk of maximum radiation exposure with
average accidental death rates in other industries is methodologically
improper and overstates the comparative risks of radiation exposure
(A.a-19, A.a-40, A.a-41, A.d-18, B.a-3, B.a-29, B.a-30, B.a-34, B.a-39,
B.a-24, B.c-12, E.b-8).
Response: We agree, and stated in the Background Report (EPA81) that such
comparison was not appropriate. Without knowledge of the distribution of-
risks that lead to the average value, it is not possible to ascertain and
compare maximum risks.
1.5.4 The risk from occupational exposure to radiation is much smaller
than other occupational risks (A.a-12, A.b-2, A.b-16, A.d-22, A.d-40,
B.a-38, B.a-39, B.c-12).
Response: One must be careful in making comparisons of radiation risks
with other occupational risks. For example, there are significant
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differences in accidental death rates among different groups of workers.
Similarly, there are significant differences of exposure to radiation
among different groups of workers. Unfortunately, appropriate data are
not generally available so that the distributions of these two different
risks can be compared. However, using available data* we can make the
following comparisons. -There are-large numbers of individuals who work in
.retail trades- and service professions and who experience very small risks
of 'accidental' de'a'th- compared to the average risk of accidental death for
all U.S...,workers. .._The estimated, incremental risk of premature death
(0.01-0.03%) "for the average worker measurably exposed to radiation (230
mrem) in-one year is less than the average annual risk of accidental death
to workers in construction (0.04%), mining (0.05%), or agriculture (0.05%)
and is higher than the average risk of accidental death for such workers
as those in trades (0.005%), manufacturing (0.006%), or services (0.007%)
in 1983 (NSC84). We finally note that a premature cancer death attributed
to radiation is not equivalent to a premature accidental death. It is
estimated- that the average number of years of life lost is 12-18 years for
a premature cancer death due to radiation, whereas it is approximately 35
years for premature, accidental death (EPA81). See also the response to
comment 1.5.3.
1.5.5 The risk at 5 rem/yr is significant, but not excessive compared
to other industries (F-3).
'Response: See the responses to comments 1.5.1, 1.5.3, and 1.-5.4.
1.5.6 Using the 1980 BEIR results, and comparing the maximally exposed
radiation workers with the maximally exposed workers in other industries,
results in comparative risk estimates almost an order of magnitude lower
than the EPA.-risk estimates (A.d-18).
Response:. We disagree. Use of the BEIR-III estimates does not result
in an order of magnitude change in these comparisons. See the responses
to comments 1.5.1, 1.5.3, and 1.5.4.
1.5.7 Comparison with the risks of other occupations is not a justifi-
cation for the acceptability of occupational risks from radiation (A.a-38,
A.c-7).
Response: The comparison of risks of other occupations with those for
exposed workers provides just one basis for judgment. We agree that
this comparison alone cannot provide justification for acceptability of
risks.
1.5.8 EPA should establish a consistent level of protection for all
industries utilizing hazardous substances (A.a-11).
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Response: Many different Federal agencies have diverse responsibilities
for providing protection of workers. In addition, the practicality of
risk avoidance may vary'widely for different hazards.
l.;5.9 'EPA assumes that-it mus± provide for a risk-free work environment,
whereas the intent of Congress was that the hazards of atomic energy be
controlled' (B.c-20). ' '':''. ' " " ' ' '
Response: . EPA does "not make such.an assumption.
1.5.10 In all risk comparisons, EPA fails to combine radiation risks with
non-radiation risks to the workers before comparing the risks to- the
workers with risks to other occupational groups (A.a-3).
Response:: .The EPA has estimated only the incremental risks of premature
death due to radiation exposure because that is the only hazard addressed
by .these recommendations. In any case, although values of average risk of
accidental death are published for some specific types of workers for whom
statistics are collected and analyzed by the Bureau of Labor Statistics
(BLS84) and by the National Safety Council (NSC84), these classified
worker groups are not also further identified as to radiation exposure. To
this end, it could be useful to have sub-code classifications for workers
exposed to radiation and other carcinogens under the Standard Industrial
Classification (SIC) code of the Bureau of Labor Statistics (BLS84). A
comparison of radiation .risk with risk of death from other carcinogenic
agents in occupational environments would be relevant, but adequate data
for such comparisons are not available. See also the response to comment
1.5.4.
1.5.11 EPA should compare the risk of cancer for radiation workers with
that of other workers occupationally exposed to carcinogenic agents
(A.d-13, A.d-22, E.a-4)..
Response: See the response to comment 1.5.10.
1.6 CONSISTENCY WITH AND VALIDITY OF ICRP-26
1.6.1 The EPA guidance should be consistent with the ICRP-26 system
of dose limitation; EPA has not sufficiently justified its deviations
from the ICRP recommendations (A.a-1, A.a-17, A.a-20, A.a-22, A.a-40,
A.a-46, A.b-16, A.b-22, A.b-23, A.d-13, A.d-22, B.a-6, B.a-12, B.a-13,
B.a-17, B.a-20, B.a-23, B.a-24, B.a-29, B.a-33, B.a-34, B.a-38, B.a-39,
B.a-46, B.a-48, B.a-53, B.c-12, B.c-20, D-6, E.a-5, E.a-6, E.a-16, E.b-1,
E.b-2, F-2).
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Response: The Agency adopts most of the basic recommendations of ICRP-26
in its final recommendations. See also response to comment 1.3.1.
l;6..2 . EPA should use ICRP-26 consistently "in toto" or reject it
completely (A.a-17, A.a-40, A.d-22, A.d-34, B.a-6, B:.a-32, B.c-20, E.a-2).
Response: The Agency adopts in its final recommendations most of the
basic, recommendations of ICRP-26, but not the contents of ICRP-26 "In
toto."" This is consistent with the following statement of the ICRP in
that publication: "Because of the differing conditions that apply in
various countries, detailed guidance on the application of its
recommendations, either in regulations or in codes of practice, should
be elaborated by the various international and national bodies that are
familiar with what is best for their needs." In addition, the premise
of the comment (that different parts of ICRP-26 are interdependent) is
not correct. Some recommendations,; such as those for overexposure, stand
alone.
1.6.3 EPA's- proposed guidance adopts- parts of the many principles and
recommendations of ICRP-26, but there are so many deviations in major
respects from the ICRP system that the intent and effectiveness of the
dose limitation system is destroyed (B.a-29, B.c-20).
Response: ' We. do not agree.'' The basic'intent and effectiveness of ICRP-26
is retained in the proposal and in the final recommendations. See also.
the responses to comments 1.6.1 and 1.6.2.
1.6.4 There is no consistent basis for the proposed limits due to
arbitrary adoption of only .selected parts of ICRP. This leads to
confusion and a loss of the basic premise of equivalent risk (A.a-11,
A.b-22, A.d-13, A.d-14, B.a-17, B.a-23, B.a-32, B.a-33, E.a-4).
Response: We do not agree. In fact, the equivalency of risk was enhanced
through the separation of "genetic and cancer risk in the proposal. See
also the responses to comments 1.6.1 and 1.6.2.
1.6.5 EPA's dose-equivalent limits are not based on specified
acceptable levels of risk, as are those recommended in ICRP-26 (A.a-46,
A.d-9, B.a-17, B.a-24, B.a-29, B.c-10, E.a-5, E.b-2).
Response: We disagree. The estimated risks corresponding to the proposed
limits were specified in the Background Report (EPA81). In addition,
since the proposed limits were only marginally different from
corresponding limits in ICRP-26, they corresponded to the same risk levels
that are "acceptable" to the ICRP. Also, see the response to comment
1.6.1.
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1.6.6 EPA should withdraw its proposed recommendations; changes
should be made only after full consideration of BEIR-III, NCRP,
ICRP-26, and other pertinent studies (A.a-18, A.a-22, B.a-7, B.a-34,
E.b-4). ' ' '
Response: -.The Agency's proposed guidance did take into consideration
the cited studies.. See also the responses to comments 1.4.1, 1.4.2,
'1.4.3, and 1.-7.1. v ' . / .
1.6.7 For the sake of political expediency, EPA ignores the
recommendations of the ICRP when they conflict with current standards and
practices (A.d-9, F-3).
Response: "Political expediency," played no part in the formulation of
the recommendations, either proposed or final.
1.6.8 The 100 rem lifetime limit is inconsistent with ICRP-26 (A.b-22,
B.a-46). ' .'
Response: Consistency' with ICRP was not a precondition for accept-
ability. The "100 rem lifetime dose" was not intended as a limit, but
as guidance for limiting career exposure. In addition, it is not
inconsistent with the ICRP. acceptable risk concepts.
1.6.9 The ICRP-26 guidance is not appropriate for regulation. Some
European nations that have adopted ICRP-26 have found it to be unworkable
(A.a-35, B.a-12).
Response:- We are aware that some practical problems in implementing
ICRP-26 recommendations exist, but they can and are being resolved.
The final guidance makes some, additions to ICRP-26 formalism to assist
in the solution of such, problems with respect to committed dose. It is
evident that some "retooling" efforts would be required to change from
pre-exis.ting radiation protection systems. It is also clear, however,
that the ICRP system has now gained almost universal acceptance in the
international community. See response to comment 1.6.2.
1.6.10 ICRP-26 concepts cannot be effectively applied for dose evalu-
ation of long-lived emitters such as the actinides (E.b-7).
Response: We disagree, in general, although some difficulties do exist.
Although the prospective control of such radionuclides is practicable,
the sensitivity of available human assay techniques is only marginally
adequate with regard to retrospective assessment of dose to individual
workers. The final recommendations recognize this difficulty and provide
for practical means of implementation.
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1.6-11 EPA's adoption of ICRP methods results in a proposed system of
guidance based on limiting the prospective dose and in which the retro-
spective dose is irrelevant. Since all dosimetry programs measure retro-
spective dose this leads to confusion in the proposed guidance (E.a-5).
Response: This is. not the. case. . The final recommendations provide that
future exposure of.the worker be appropriately managed where assessment of
actual intakes* of 'radioactive materials shows conditions for limitation of
intake (past) have not been met. In further response to this comment, we
offer'the following quotes from ICRP-26 (page 16): "In principle, the use
of the dose-equivalent commitment concept does permit the dose equivalent
received in a single year to exceed the annual limit (e.g., in the case of
an intake in 1 year of a material of long effective half-life, followed by
an intake in the next year equal to an ALI of a material of short
effective half-life). In practice such situations will be rare and the
dose equivalent -during any year in excess of the annual limit will
normally be small...." "The dose-equivalent limits should not be regarded
as a dividing line between safety and danger; when limits have been
exceeded by a small amount it is generally more significant that there has
been a failure of control than that one or more individuals have slightly
exceeded a certain agreed dose." See also the response to comment 2.1.11.
1.6.12 ICRP-26 reverses the trend for reducing radiation exposure to
workers> . It_recommends changes that would increase exposures to sensitive
organs where.radionuclides are'deposited' in one organ alone (C-6).
' .
Response: Although the statement may be true for some limited examples,
the reverse is true for the majority of situations. The organ dose limits
in the current (old) system were not set on the basis of equivalent risks.
ICRP-26, however, limits the annual dose to a given organ on the basis of
its weighted .stochastic risk .(genetic plus somatic),, relative to that of
whole-body,, and additionally (when applicable) restricts it to a limiting
dose of 50 rems (15 rems to lens of eye) to prevent non-stochastic effects.
Consequently, some derived limits for radionuclides increase and others
decrease. However, even in the case of a numerically higher derived limit
workers would not necessarily be subject to higher doses. The ALARA
principle is still a radiation protection requirement.
1.6.13- The ICRP-26 limit of 50 rems per year for single organ exposure
cannot be shown to adequately protect worker health (C-6).
Response: This limit applies to non-stochastic risks only, and the
commenter does not supply any evidence that such risks are significant at
this dose. Also, see the response to comment 1.6.12.
1.6.14 Nearly all members of the ICRP have been employees of
governmental atomic energy agencies or have worked in government-related
laboratories .and are unlikely to be inclined to reach conclusions that
make nuclear energy more expensive or difficult (A.a-38).
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Response: The Agency concluded that an overall limit of 5 rem/yr was
appropriate independent of ICRP recommendations.
1.7,.. .. .CONSISTENCY WITH NCRP
1-. 7..1 .-v-'The proposed limits should.be consistent with the recommendations
of the NCRP (A.a-15, A.b-15, A.b-16, A.b-22, A.d-9, A.d-12, A.d-22,
A.d-34, A.d-15, A.d-22, B.a-5, B.a-32, B..a-34, B.a-53, E.a-5, E.a-7,
E.b-4).
Response: In formulating the proposed recommendations, the Agency took
NCRP recommendations into consideration. We have also consulted with the
NCRP in our consideration of final recommendations. However, the Agency's
final recommendations are based on ICRP recommendation and cannot at the
same time adhere strictly to all of the recommendations of NCRP. (There
is no legal.requirement for such consistency of Federal radiation
protection guidance.) We do adopt, however, those elements of NCRP
recommendations 'that are appropriate', such as their recommendations
concerning exposure of the unbor-n, and these recommendations provide
overall protection consistent with NCRP recommendations.
1.7.2 The proposed changes in the RPGs should be reviewed and approved
by the NCRP before any significant changes are promulgated (A.a-40,
A.b-15, A.d-9, A.d-22, B.a-34, E.a-5, E.b-4).
Response: See the response to comment 1.7.1.
1.7.3 Both the ICRP arid NCRP are'reviewing their radiation protection
standards; adopting new RPGs before the positions of the scientific
community are established is not needed and will not improve personnel
safety (B.a-24, B.a-34).
Response: Both ICRP and NCRP have their current recommendations under
continuing review. The existing Federal radiation protection guidance for
occupational exposure has not been changed since its approval in 1960.
EPA, in view of its responsibilities, considers it appropriate to review
the guidance, and to update it in light of its findings and of significant
advances since 1960. We have concluded that changes are needed and will
improve radiation protection of workers.
1.7.4 The EPA method of calculating radiation exposure, based on the
1977 recommendations of the ICRP, has not been recommended for use by the
NCRP (E.a-5).
Response: See the response to comments 1.7.1 and 1.7.2.
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1.7.5 . The NCRP, as. well as other scientific advisory groups, have, found
after continuing review that there is no need for a downward revision of
the RPGs (B.a-12, E.b-4). . '
Response: The comment is incorrect. The NCRP has recommended adoption of
a 5--rem/yr limit-. Se.e also the response to comments 1.3.1, 1.6.12, and
. l.T.i. . .. . - . ' . . . ' " '
1.7.6 The proposed organ limits differ from the limits accepted by the
NCRP (B.a-14). .
Response: See the response to comment 1.6.12.
1.7.7 The 100 rem lifetime limit is inconsistent with NCRP recommen-
dations (A.b-13,. A.b-22, B.a-38).
Response: See the response to comment 1.6.8.
1.7.8 Scientists working in the NCRP have a number of potential biases
due to their affiliations; these biases make them less appropriate
arbitrators of the risks that other individuals should accept than
scientists, whose., .livelihoods are not so. directly related to the day-to-day
use of radiation (A.a-38). ' '"''
Response: The recommendations were based on EPA's independent assessment.
1.8 COORDINATION'WITH, OTHER U.S. AGENCIES.
1.8.1 There is a need to develop one set of guidelines applicable to all
Federal agencies (A.b-20, A.d-8, A.d-27, B.a-3, B.a-8, E.a-2, E.a-3,
E.a-4, E.b-1).
Response: These recommendations for Federal radiation protection guidance
for occupational exposure are applicable to all Federal agencies.
1.8.2 EPA's proposed guidelines are inconsistent with NRC's recently
promulgated regulations. The discrepancies should be resolved (A.d-14,
-A.d-29, A.d-40).
Response: The NRC has only recently, December 20,1985, proposed its draft
revisions to 10 CFR Part 20 (NRC85); final promulgation is not likely to
occur in less than several years. In any case, NRC will revise its
regulations as necessary to conform with newly approved Federal guidance.
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1.8.3 EPA's proposed guidance is too restrictive. Standards should be
set by the federal agencies; generic guidelines for these standards should
be written by EPA (D-10).. ." . _
Response: The division of responsibility proposed by'the commenter is
that actually, in effect. EPA's statutory responsibility in the area of
radiation protection for occupational exposure consists of making
recommendations to the-President for the guidance of Federal agencies in
their formulation of radiation standards. Regulatory Federal agencies
translate this guidance into regulations.
1.8.4 The following sentence should be added for clarification: "These
proposals have not had a formal review by these agencies and, therefore,
they do not carry the endorsement of these agencies" (E.a-4).
Response: In the section titled "Previous Actions by EPA" of our proposed
guidance (46 F.R. 7836), we stated: "These agencies, which have not
formally endorsed these recommendations, will formally review final
proposals when they are developed following public review."
1.8.5 EPA should clarify the role to be played by the Interagency
Working Group during the remaining phases of this review (E.a-4).
Response:' In 'the'section titled "Previous Action by EPA"'of our proposed
guidance (46 F.R. 7836), we st.ate that the role of the "Interagency work
group" is an advisory one: "In developing these proposals, we have also
consulted with the technical staffs of the Federal agencies that regulate
or influence the regulation of occupational exposure, and will continue
this consultation in developing final recommendations." The final
recommendations represent the result of this consultation with affected
Federal agencies.
1.8.6 All federal .agencies concerned with radiation should have the.
technical capability for independent evaluation of scientific evidence
upon which the standards to minimize exposures to radiation rest (A.a-38).
Response: We agree that this would be desirable, to the extent required
to carry out their responsibilities.
1.9 ECONOMIC COSTS AND COST/BENEFIT-
1.9.1 EPA's estimate of total cost to comply with regulations
($35 million) is simplistic, theoretical, and/or wholly unrealistic
(A.a-3, A.a-13, A.a-31, A.d-9, B.a-5, B.a-9, B.a-28, B.a-33, B.a-46,
B.c-22).
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Response: EPA funded an independent study, "Analysis of Costs for
Compliance with Federal Radiation Protection Guidance for Occupational
Exposure; Volume I: Cost of Compliance with Proposed Radiation Protection
Guidance for Workers, and Volume II: Case Study Analysis of the Impacts of
Proposed Radiation Protection Guidance for Workers (November 1983)," to
provide cost estimates for the proposed guidance (EPA83a-)« In. addition,
the NR.C funded a similar -study, "Cost of Compliance with Occupational
Exposure Revisions to 10 CFR. Part 20" (December 1982)," to provide
estimates for. implementation of Federal guidance (NRC82). These cost
analyses by Jack Faucett Associates and S. Cohen Associates, Inc. (JFA/SCA)
are based on case studies of representative establishments in conjunction
with industry profiles and are extrapolated to the entire private industry
sector. Several cost estimates were updated for the NRC as a result of
changes to draft revisions of 10 CFR Part 20 (Coc83, Lad84). Some of the
estimated costs are attributable to changes in guidance, while others are
attributable to regulatory updates necessitated by changes in scientific
information; these are discussed below.
The summary costs for implementation of new recommendations
include NRC licensed operations in Federal agencies, but do not include
activities ofFederal agencies exempted under the Atomic Energy Act. To
confirm that there are no unusual new requirements for Federal agencies
that will require above normal program costs, EPA's case studies (EPA83a)
included two Department of Energy facilities, Rocky Flats Plant and Idaho
National Engineering. Laboratory, where the normal operations include
routine bioassay programs for surveillance of workers subject to internal
exposure. -These were selected, to assess unusual costs where the greatest
impacts would be expected in implementing the final recommendations.
Because the workers are not currently exceeding the annual effective dose
equivalent of the final recommendations from combined internal and external
exposures and since the affected agencies routinely update their radiation
safety programs, the associated costs would be part of normal operations.
Costs of. implementing the 5-rem limit (0.3 $M initial plus
0.75 $M annually), ALARA (2.16 $M initial plus 1.48 $M annually), and the
new limits for the unborn (0.06 $M annually) are shown in the first three
entries in the table below. The JFA/SCA cost estimate for instruction on
levels of risk (9.87 $M annually) is high, since much of this instruction
is possible within existing programs and/or with appropriate written
materials. In addition, only new workers would lead to recurring annual
costs. We have assigned 60% of the JFA/SCA cost estimate to recurring
annual costs.
There normally are some costs due to revision of manuals and
procedures for carrying out new regulations. However, the JFA/SCA
estimates of costs for manual/procedure revisions (10.74 $M initial only)
are primarily for implementation of new dosimetric models and summation of
internal and external doses. These costs are not attributable to changes
in guidance; they would also be incurred under existing guidance.
Therefore, costs for manual/procedure revisions (shown in parenthesis) are
omitted from the total.
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Table 3. ESTIMATED IMPLEMENTATION COSTS
(thousands of 1982 dollars)
One-time .
Initial
Annual
Provision
Change
$300
$2160
$3950
($10740
$750'
$60
$1480
$5920
**
5 rem limit
Unborn (0.5 rem
limit)
ALARA program
Levels of risk
.instruction
Manual/procedures
revision
Reduction from 12 to 5 rem
maximum dose.
New requirement.
Re-emphasized requirement.
New requirement.
New dosimetric models
(update under 1960 guidance)
$6410'.'. ' $8210 .
Total
These values are high, since they are based on hiring experts to con-
duct instruction. Much of this instruction should be possible within
existing programs and/or with appropriate written materials. Initial
costs for all workers need not be repeated; only new workers generate
recurring annual costs. Thus, only 60% of the JFA/SCA annual cost
estimate ($9,870,000) has been assigned to recurring annual costs.
**
Only a very small fraction of this cost is attributable to proposed
changes in Federal guidance, since these costs are almost wholly
generated by the need to update allowed values of radionuclide airborne
concentrations (to conform to new scientific information) and to sum
internal and external doses; these changes would also be required under
existing guidance.
Some costs are attributable to new monitoring needs (due to changes
in scientific data that reduce limiting values of radionuclide
concentrations in air or water) or to summation of external and internal
exposure. Since these are necessary under existing guidance, the JFA/SCA
cost estimates for internal exposure monitoring (8.7 $M initial plus
4.1 $M annually), retraining (3.61 $M initial), recordkeeping (3.67 $M
initial plus 0.14 $M annually), and reporting (0.18 $M annually) are not
due to new provisions and, therefore, not included in Table 3.
The total estimated costs attributable to changes in guidance are
therefore a first-year total cost of $14.62 million and subsequent annual
costs of $8.21 million. Since the estimated costs of instruction on levels
of risk are believed to be too high, realistic costs of about $10 million
in the first year, and about $5 million annually, thereafter, appear more
likely.
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1.9.2 Administrative detail/recordkeeping will be a significant portion
of the costs that would occur should the regulations be promulgated
(A.a-10, A.b-15, B.a-32, B.a-37, B.a-48, B.b-1).
Response:. We agree that there would have been additional administrative
detai-1/recordkeeping costs associated .with .implementation of the proposed
recommendations. However,, the final recommendations do not lead to such
additional costs. While it is true that the NRG proposed revision of 10
CFR 20 (NRC85)' will lead to costs for manual/procedure revisions, these
costs would occur under existing guidance and are not attributable to
changes in Federal guidance. See the response to comment 1.9.1.
1.9.3 The additional cost to U.S. industry inhibits its ability to
compete with foreign producers (B.c-22).
Response: We disagree. Workers around the world have experienced levels
of exposure comparable to those of U.S. workers (UN77, UN82) and operate
under, regulations requiring levels of protection comparable to those
recommended here for U.S. workers.
1.9.4 To remove flexibility, such as stated on p. 7838 (46 F.R. 7836)
for the overall cumulative limit [5 (N-18) rems] will result in more
unnecessary regulatory procedures at increased cost to the taxpayer and
consumer (A.a-31). ' '
Response: We disagree. We do not believe that repeated exposures at or
near the 3 rem quarterly limit in a given year are justified in view of
the estimated risks. Removal of the 5(N-18) rems and 3 rem quarterly dose
limitations leads to small increased hiring/training of some additional
workers. Although those workers eligible under the 5(N-18) cumulative
dose limitation to receive 3 rems per quarter and up to 12 rems per year
will no longer be allowed, to exceed 5 rems per year, no single job
currently requiring 3 rems will be affected by the new limitation.
1.9.5 Training of additional workers will be costly, and will actually
lead to increased risks, as more workers will be exposed, raising the col-
lective dose. Further, there is a shortage of workers able to qualify as
inspectors (A.d-40, B.a-21, B.a-28, B.a-37, B.a-44, E.a-3, E.b-6, E.b-55).
Response: Where additional workers are necessary there will be incremen-
tal costs for workers and their training. The total costs estimated for
meeting the 5 rem limit are $300 thousand (initial)and $750 thousand
(annual) (NRC82). We do not believe that there will be increases in
collective dose or risk as a result of final recommendations (see the
response to comments 2.7.2 and 2.7.6). In addition, some period of time
will elapse between Presidential approval and regulatory implementation of
the guidance, so that the training of new workers can be anticipated and
carried out over a reasonable period of time; the NRC regulatory implemen-
tation proposes a five year period (NRC85). See the responses to comments
2.3.5 and 2.7.4.
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1.9.6 The present economic situation of the U.S. makes these
recommendations particularly ill-timed and unjustifiable (A.a-3, A.d-21,
A.d-25, A.d-31, B.a-26, B.a-54).
Response: The incremental costs of implementing the new recommendations
are.small fractions of existing costs of radiation protection or health
and safety programs. Furthermore, such costs are inherent to an
acceptably safe program for workers, regardless of economic situations.
1.9.7 The cost of the EPA recommendations is not justified as the
resultant benefits are not recognizable, or are insufficient to justify
the cost (A.a-31, A.a-34, A.a-41, A.a-46, A.b-10, A.d-21, A.d-27, A.d-40,
B.a-21, B.a-28, B.a-54, B.b-3, B.c-9, B.c-12, D-2, E.a-2).
Response: These recommendations are the result of over ten years of
extensive, review and deliberation by Federal agencies and other interested
parties. The recommendations are in accord with the internationally-
accepted recommendations of ICRP-26. We expect that the implementation of
this' guidance will lead to appropriate protection of the unborn and to few
workers approaching the annual limiting effective dose equivalent of 5
.reins and that overall exposure to workers will decline. The latter
benefits should be readily documentable after the new limits go into
effect. See also the response to comment 1.11.19.
1.9.8 ' We suggest that the EPA perform a cost benefit analysis before
releasing these recommendations (A.a-11, A.a-13, A.a-23, A.b-11, A.b-17,
A.d-14, A.d-31, A.d-35, A.d-40, B.a-17, B.a-29, B.b-5, B.c-20, D-2, E.a-5,
E.a-6, E.b-5, E.b-6, E.b-9).
Resppnse.: The EPA has conducted an assessment of the estimated costs of
implementation and expected benefits. See the responses to comments
1.9.1, 1.9.2. 1.9.5, 1.9.7, 1.9.11, 1.9.13, 1.9.16, and 1.9.17.
1.9.9 Presidential Executive Order 12291 requires cost benefit"
assessment before the release of regulations that may have a major effect
on the public. EPA did not supply this analysis. (A.b-4, A.d-25, A.d-27,
B.a-14, B.a-32, B.a-38, B.a-48 B.c-2, B.c-22).
Response: Executive Order 12291 applies only to rules (regulations) that
may have a major impact on the economy ($100 million or more per year);
would result'in major increases in prices and costs; or would have
significant adverse effects on competition, employment, investment,
productivity, or innovation. We have judged these recommendations would
not qualify under any of these criteria.
1.9.10 Money could be more effectively spent on worker safety than by
reducing one cancer death at a cost of fcl million (EPA estimates reducing
cancer deaths by 35 at a cost of $35 million) (A.a-12, E.a-5).
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Response: Agency guidelines suggest that the value of a statistical life
be established in the range-of $0.4 to 7.0 million in 1982 dollars
(EPA83b). The value cited falls within this range.
1.9.11. /The added cost.of one person to the radiation safety programs of
hospitals; alone.is estimated.at $40 million. This assumes 2,000 new
hospital hires '(radiation protection personnel) @$20,000/hire =
$40-million (A.d-14,. A.d-40)..,;, .,..-.-. -. . . ...
Response: -The--costs of implementing the supervisory requirements of the
proposed Minimum Radiation Protection Requirements for Range C were quite
large when .based on a strict interpretation of the proposal. However,
such costs will not occur due to elimination of these requirements. The
estimated costs for implementation of the final recommendations by
hospitals, is $5.1 million for the first year and $3.1 million annually
thereafter (EPA83a, -NRC82). These costs include part-time consultants
(these eliminate the need for hiring new full-time employees) for
training/instruction on levels of risk. Other costs associated with
monitoring of internal exposure, regulatory reporting, and
manual/procedure, revisions are riot attributable to new recommendations;
they would be incurred as a result of utilization of new dosimetric models
and summation of internal and external doses under existing guidance. See
also the response to comment 1.9.17.
1.9.12 If dose.limits are to be decided by what a given industry can
afford, then EPA should abandon all attempts at estimating risk from
actual data, and leave it to the economy to set radiation levels (A.c-6).
Response: The basis for setting the dose limits was not what an industry
can afford. . .- . . . .
1.9.13 Increased labor cost for commercial light water reactors is
estimated at a minimum of $152 million per year (B.a-3).
Response: Increased labor cost to meet the 5 rem limit is estimated to be
$340 thousand per year for- all 1982 nuclear power reactors (NRC82).
1.9.14 Additional costs for the Department of Defense due to a reduction
of the RPG from 5 to 0.5 rem are estimated at $12 million initially, and
$4 million annually thereafter (E.a-2).
Response: Since the dose limit adopted in final recommendations remains
at 5 rems, these incremental costs will not occur.
1.9.15 Industry should estimate the cost .due to the proposed
recommendations'(B.a-16).
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Response: The EPA is aware of one such study. An assessment of the costs
associated with the "Dosimetry and Recordkeeping Implications of the
Proposed Revisions .to 10 CFR 20" was sponsored by the Atomic Industrial
Forum, Inc. (AIF80). This.assessment only included consideration of
nuclear power plants and fuel fabrication, facilities.
l:.9.1-6 ' Overall, medical, costs continue to rise, while technical
.radiologic. workers; continue-to be underpaid. . Understaffing in this area
is severe: EPA's additional regulatory burden would only exacerbate a
serious problem (A.d-39). . . : .
Response: The final recommendations do not result in significant needs
for additional full-time radiation safety staff. Much of the training on
the subject of worker risk (EPA83a) can be handled by part-time
consultants. See the response to comment 1.9.11.
1.9.17 .The cost to patients, hospitals, and insurers will increase
significantly if the recommendations are instituted (A.d-27).
Response: We disagree. With over 36 million admissions (and over 200
million outpatient visits per year) to U.S. community hospitals in 1980,
the incremental cost to admitted patients from implementation of the final
recommendations would average.less than $0.14 per patient for the initial
year ($5.1 million first-year costs) and $0.08 per patient for each year
thereafter ($3.1 million- annual costs). These costs would be more than
six times smaller if outpatients also shared these costs. In either case,
the incremental costs are trivial compared to average expenses at
community hospitals amounting to about $1,900 per admission and about $250
per inpatient day in 1980 (AHA81). See also the response to comment
1.9.11. ...
1.9.18 . Utilities would need to evaluate internal procedures, retool
recordkeeping, and re-educate its work force, all at significant cost
(B.a-37).
Response: We agree that there will be some incremental costs associated
with these activities. See the responses to comments 1.9.1 and 1.9.2 for
proper assignment of such costs to new recommendations or existing
guidance.
1.9.19 A study for AIF indicates that for nuclear power facilities one
could expect an adverse negative impact exceeding the benefits to be
derived from the proposed 100 rem lifetime limit (B.a-50).
Response: Although we do not agree with this conclusion, the comment is
moot because this proposed lifetime dose figure does not appear in final
recommendations.
40
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1.9.20 . The EPA should fully evaluate the impact of its recommendations
on waste management and disposal facilities and spent fuel reprocessors
(B.a-32). \ .
Response: EPA requested comments on its proposed guidance from all
interested persons, in,all -types of activities involving radiation
exposure of workers. The comments received have been taken into
consideration in formulating final recommendations. Additionally, a
two-volume report, was prepared for. EPA regarding the impact of the
proposed guidance and the cost of compliance with that guidance (EPA83a).
The report was based on case studies which involved qbtaining first-hand
information from a number of activities representative of the spectrum of
diverse types of facilities involving occupational exposure, in both the
public and private sectors. Included in these studies are waste-
management and fuel reprocessing. We analyzed the results of these
contract studies and took them into consideration in formulating final
recommendations. See the response to comment 1.9.1.
1.10 ' RECORDKEEPING '
1.10.1 The recordkeeping requirements associated with the proposed
guidelines would result in increased.costs to those regulated, with
little-, if any corresponding benefit (A.a-11, A.a-26, A.b-IO, A.d-14,
A.d-39, B.a-d, -B.a-1, B.a-12, B.a-13, B.a-36, B.aySS, B.a-54, E.a-5).
Response: Changes in recordkeeping requirements are best inferred from
the final recommendations, which may entail some new recordkeeping costs.
However, our assessment showed that final recommendations do not lead to
additional recordkeeping costs over those that would occur under existing
guidance. See-the responses to comments 1.9.1 and 1.9.2 for more detailed
discussions.
1.10.2 Eliminating recordkeeping by substituting the three-tiered
grading system is not advised, as it may invite noncompliance due to its
complex nature (A.a-5, C-6, E.a-5).
Response: It was not intended to eliminate recordkeeping practices
through use of the "three-tiered" system.
1'. 10.3 All workers should be given access to their records and the
records should be made available for epidemiological research (B.a-38,
C-6).
Response: The recommendations contain explicit provision for informing
workers of their exposures. There may be valid reasons why an employer
41
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should not make radiation exposure records available to anyone requesting
them for epidemiological or other research. A worker's radiation exposure
record is in some respects akin to his medical record and should therefore
be handled accordingly. When these matters are handled in accordance with
law, we agree that there may be value in using worker exposure records for
e.pidemiological studies, .particularly if ..the .technical do-simetric data on
which.those .records are based are also made available to and used by the
investigator. .However,' legal aspects of access to radiation exposure
records- are. not within the scope of these recommendations.
1.10.4 Additional lifetime recordkeeping requirements can be instituted
at minimal cost as the requirements differ little from current practice
(A.a-38, A.a-39).
Response: We believe this is true for most existing recordkeeping systems.
1.10.5 The impact on the practice of medicine will be almost exclusively
to increase administrative recordkeeping (A.b-4).
Response: . See the response to comment 1.10.1 above.
1.10-6 .The elimination of Form. NRC-4 is not .compatible with other
changes -in notification and reporting requirements (B.a-38).
Response: Such a decision by the NRC "is outside the scope of- Federal
radiation protection guidance.
1.10.7 Records should be-kept on diseases and defects of worker's
children (A.c-6).
Response: This comment is outside the scope of consideration for these
recommendations. . .
1.10.8 A central data bank of radiation exposure histories for permanent
and temporary workers is needed (A.c-6).
Response: Such a data bank could serve a number of useful functions.
However, this matter is outside the scope of consideration for these
recommendations.
1.11 MISCELLANEOUS
1.11.1 EPA's Federal Register Notice is inadequate in that it does not
address the issues raised by NRDC, et al. (A.a-5, A.c-3).
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Response:' We disagree. The issues listed in the proposal (46 FR 7836),
and discussed more completely and extensively in the background report
(EPA 520/4-81-003), encompass the issues raised by NRDC. .Additionally,
and as stated in the Public Hearings sections of the Federal Register
notice containing the proposed recommendations, "The issues to be covered
by these hearings, are those listed a-bo.ve under the heading 'Issues
Addressed.'-' "They include those listed in our advance notice of September
'17,. 1979 (44 FR 53785) and additional issues suggested since then. As
indicated in that notice, both EPA and NRC have been petitioned by the
Natural Resources Defense Council, Inc., to revise occupational guidance
a-nd standards. The subject matter of these hearings encompasses the
issues raised in those petitions (See 40 FR 50327 of October 29, 1979)."
The Agency considered the NRDC petitions in formulating both its proposed
and final recommendations. Explicit issues are addressed in the detailed
subheadings of this response to comments.
1.11.2 'By relaxing certain organ dose limits, EPA is inviting public
criticism (A.a-3).
Response: We invited the public to- comment, on our proposal, and received
a large number of both written and oral comments. We did not anticipate
all comments to be positive, and they were not. However, as promised, we
have carefully considered all of them in- preparing final recommendations.
1.1T.3 Cost-benefit -analysis is irresponsible until all premature.deaths
are eliminated (A.c-8).
Response: Cost benefit analysis after elimination of all premature deaths
would be meaningless. In the context of the models used to estimate the
risk of premature death from occupational exposure to radiation,
elimination, of all such premature deaths would require completely
eliminating all such exposure. This, if it were feasible, would require
elimination of all.activities and radiation sources giving rise to any
exposure. Also, see the response to comment 1.3.10.
1.11.4 We encourage EPA to take to heart the comments of the Health
Physics Society (A.a-41, A.d-1, D-10).
Response: The Society's comments have been taken into consideration. See
the response to comment 1.3.2.
1.11.5 New York City and Boston should have been public hearing sites
(D-5).
Response: We regret that due to limited resources available, we were
unable to hold public hearings in New York City and Boston (as well as in
other cities). We conducted a carefully researched selection process for
the hearing sites so as to afford an opportunity for attendance by as many
and as diverse types of workers and interested parties as possible.
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1.11.6 Submitted comments are not adequately considered (B.a-31).
Response: We have made every effort to do so.
r'l>ll;7. . EPA should- incorporate notes-into the. recommendations (B.c-22).
Response: The "notes" are designated as such because they are of an
:-explanatory, nature,.' not- basic- requirements. However, since they serve to
clarify the intent or application of the recommendations, they should be
considered to be effectively part of them.
1.11.8 "Guidance" will become "regulation" (B.a-10, E.b-8).
Response: We hope so. Radiation protection guidance is for the use of
Federal agencies in the-conduct of their radiation protection activities,
which includes the development and enforcement of standards. -Guidance,
however, is intended to be used with a degree of flexibility.
1.11.9 Include the background report as a part of the guidance when
completed.(A.b-5).
Response.: The President approves only the recommendations themselves as
Federal guidance. '-However, the background report may bV used to clarify
th*e intent"of the guidance. -
1.11.10 Effective radiation safety is not related to legalistic endeavors
of pressure groups, government bureaucracy, or political expediency
.(A.a-26)» ... . .
Response: The comment is not necessarily correct. Endeavors of "pressure
groups" (environmental, industrial, worker, women's rights, etc.) often
serve to call attention to the need for a change or to whether a change is
desirable. They are a legitimate part of the existing institutional
framework of democracy in this country. Radiation protection of workers
is a legitimate concern of many of these groups.
Further, an effective national radiation protection program that
excludes the active participation of government is difficult to envision.
However, we certainly agree that "political expediency" does not serve a
useful role in the formulation of radiation protection guidance, or, for
that matter, in radiation protection in general. See also the response to
comment 1.6.7. /
1.11.11 Independent researchers must be granted access to the atomic bomb
casualty data (A.a-7).
Response: These data are not within EPA's jurisdiction.
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1.11.12 The recommendations are unfeasible (A.d-40).
Response: We disagree. See, for example, the responses to comments 1.6.9
and 1.6.10 regarding specific provisions.
1.11.13' Why did EPA request comments from the public before requesting
them from other federal agencies (A.a-18)?
Response: Representatives" of the principal Federal agencies played an
active role in the formulation of both the proposed and final
recommendations. Also, see the response to comment 1.3.4.
1.11.14 The nuclear power industry will need an approximately 2 years
implementation period (B.a-20).
Response: We recognize that certain types of regulated activities will
require more time than others to implement the regulatory changes resulting
as a consequence of new guidance. We-have explicitly recognized that
regulatory agencies should allow an appropriate amount of time for
compliance-with regulatory changes. See the response to comment 1.9.5.
'1.11.15 The requirement to "provide an estimate" if finally determined
personnel monitoring results are not available- at the time of termination
does--not address the issue of who is responsible if the estimates prove _ .
incorrect.(B.a-38). " *
Response: No response required. This comment is apparently meant for an
NRC proposed rule. The EPA proposal did not cover record requirements for
termination of employment..
1.11.16 The guidelines mean nothing if there is no enforcement mechanism
(A.c-7, C-5, D-l).
Response: The regulatory Federal agencies (and those of Agreement States)
translate Federal guidance into regulations which they then enforce.
1.11.17 EPA perpetuates itself by establishing guidelines that will be
enforced by EPA (B.a-26).
Response: EPA has a statutory responsibility to recommend Federal
radiation protection guidance. Upon approval by the President, Federal
agencies develop regulations which they themselves prepare and enforce.
In occupational radiation protection matters, EPA is not one of these
regulatory agencies, and hence it is not an enforcer.
1.11.18 A number of the proposed provisions could be disastrous to the
medical radiation field (A.d-5).
45
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Response: We disagree. Large costs of implementation were suggested
by some commenters who made erroneous interpretations of the proposed '
recommendations. See the responses to comments 1.9.11, 1.9.16, and
1.9.17.
1.11.19 The statement "on page 7'84l, "If this new guidance is adopted,
workers-should :be-harmed les'S in the future," is unsupported by any
evidence presented (A.d-5).
Response: The .proper interpretation of this sentence is that the Agency
believes that proposed guidance should lead to lower average annual doses
to workers. The. text also acknowledged that it was not possible to
quantify this belief because EPA cannot predict how effectively these
recommendations will be implemented.
1.11.20 EPA should place emphasis on overall assessments of radiation
exposure as they appear in the perspective of a national radiation budget
(B.a-35).
Response:- There is no "national radiation budget" nor, in our view,
should there be one. All exposures should be justified on their own
merits. This principle is basic to all radiation protection, and has been
for many decades. .- . .
1.11.21 EPA should propose an agency-wide federal ALARA program-designed
to reduce population exposure to ionizing radiation. This should be
organized along co.st-benefit evaluations so as to achieve maximum
reduction in person-rem per dollar spent (B.a-35).
Response: We thank the commenter for this suggestion, but feel that it is
not appropriate for EPA to propose a detailed ALARA program for
occupational exposure. (These recommendations do not address exposure of
the general public.) The requirement for ALARA programs, however, is
contained in the recommendations and such programs are the responsibility
of the implementing agencies.
1.11.22 EPA should coordinate with other agencies of Government a 10-year
program targeting a national annual dose reduction of 5 million
person-rems by 1990 (B.a-35).
Response: The comment provided a table giving a U.S. population dose of
45 million person-rems of which 22.5 million person-rems and 22.0 million
person-rems were for natural radiation and patient medical radiation
exposure, respectively. Since national occupational exposure was only
0.15 million person-rems in 1980, such a program is not relevant to
occupational exposure, which is the subject of this rulemaking.
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1.11.23 EPA should provide the American people with a timely annual
report on radiation exposure, similar to the NRPB document, Radiation
Exposure of the UK Population" .(B.a-35).
Response: EPA prepares reports-on occupational exposure in the USA at
f-ive-yea-r intervals. The 'first report'- [EPA 520/4-8.0-001] was for 1975;
the second report, [EPA 520/1-84-005], covers 1980. We.have found that the
preparation of these reports is time-consuming and costly and that some
.data-are difficult.-to obtain. However, since, radiation exposures change
relatively slowly over time, an- annual report is not necessary.
1.11.24 The EPA should establish an Industrial Advisory Committee with
representatives from industry and professional societies to advise on
occupational issues relating to ionizing radiation (B.a-35).
Response:- EPA provides' for input from such groups on the same basis as
other special interests and members of the general public; that is,
through the mechanism of public hearings and comment.
1.11.25 EPA should form an Ad Hoc group, to visit operating commercial
power facilities, so as to gain first-hand knowledge of radiation
protection practice (B.a-35).
Response: -EPA'staff and that of other Federal' agencies that participated
in.the formulation of these recommendations include personnel with such
first hand knowledge.
1.11.26 EPA should recognize that its guidance on radiation protection
does not have the force of .law in. the courts. It should coordinate an
effort by federal agencies to develop information on radiation risk that
would be useful to the courts and to the Congress (B.a-35).
Response: We do recognize that it is not guidance, but regulations (based
on guidance) that "have the force of law in the courts." We have
sponsored all of the definitive reviews of radiation risk carried out by
the National Academy of Sciences since 1970, and will continue to do so.
1.11.27 The purpose of the guidance is to deal with risk to the worker,
not measure societal cost (A.a-38).
Response: An important component of societal cost is the total detriment
to workers. The recommendations seek to minimize this detriment (i.e.
collective dose), while also assuring an appropriate level of protection
to individual workers.
1.11.28 The draft proposals would not in the aggregate be beneficial for
among other reasons, there are no directly identifiable health effects for
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exposure levels imposed by current RPGs and EPA declines to recognize any
obligation to justify the costs of its actions to the users of ionizing
radiation (A.d-40).
Response: There is clear societal recognition and acceptance of the need
to set radiation., protection standards at. levels lower than those at which
health effects are observed. Although there should be no directly
observed health effects, 'we-have estimated the range of health effects
anticipated, at occupational.levels of exposure. See also the responses to
comments 1.3.1, 1.4.6, 1.4.7, 1.4.9, 1.4.10, 1.4.26, and 1.9.1.
1.11.29 The proposed guidelines remove any of the flexibility to
administer a total program of radiation safety (E.b-9).
Response: "We disagree. No evidence has been advanced to support this
comment. We believe,'along, with, participating Federal agencies, that the
recommendations provide for appropriate flexibility throughout.
l.llvSO Are federal agencies required to implement the guidance (A.a-5)?
Response: Upon the President's approval of EPA's recommendations, they
become a Presidential directive to the Federal agencies.
1.11.31 .The proposed guidance will be binding upon radiation workers but
not federal regulatory agencies (A.d14).
Response: Federal guidance is not directly binding on workers,
regulations derived from guidance are binding on their employers. The
recommendations are for. the guidance of Federal agencies in the conduct of
their radiation protection'activities, including the development of their
regulations. Also, see the response to comment 1.11.30.
1.11.32 EPA's proposal will be beneficial to individual workers at the
expense of society because of i'ncreased collective dose. (A.b-4).
Response: We do not agree that -there is any need for increased collective
dose under these recommendations, which replace the former (3 rems)
quarterly limit with a higher (5 rems) annual limit. See also the
response to comment 2.1.5.
1.11.33 Death certificates should tell how long a person had a given
disease (A.c-6).
Response: None required. Such requirements are outside the scope of
Federal guidance.
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1.11.34 Existing guidance purports to be 5 rems per year; this is more
myth than reality (A.c-6).
Response: In existing Federal guidance (25 FR 4402) for radiation
workers, the limits for whole-body exposure are: a dose of 3 rems per 13
weeks;- and an accumulated dose -(in rem)- of..5.times the number of years
beyond age 18 [i.e. accumulated dose'of 5 (N-18) rems]. Thus, some
workers.could be permitted to receive a dose of 3 rems for 4 consecutive
quarters-, that is,--12..rems in a given year. The notion of "5 rem per
year" in connection with the existing guidance therefore refers to the
average' annual limit over a working lifetime and not necessarily to the
limit in any one year.
1.11.35 X rays do not prevent anything; the semantics on this point
should be cleaned up in the guidelines (A.b-4).
Response: The final recommendations have been carefully edited to prevent
unintended implications.
1.11.36 The guidelines should be based on a more carefully critiqued
background document (A.b-4).
Response:- Comments- received on-.our proposed recommendations and
background'report were taken into'consideration in preparing final
recommendations and this response to comments.
1.11.37 What is the legal, meaning and definition of the proposed Guidance
in regards to other government agencies and the private work place (A.a-5).
Response: See the responses to comments 1.11.8, 1.11.16 and 1.11.17.
Federal- radiation protection guidance affects the private work place via
the regulations of cognizant Federal agencies (and Agreement States).
1.11.38 We question the authority of EPA to prescribe regulatory
approaches for all other Federal agencies (B.a-38).
Response: In our proposal (46 FR 7836) we cited EPA's statutory authority
in the following statement:
"Statutory Authority: The Administrator of the Environmental
' Protection Agency (EPA) is charged under Executive Order 10831,
Reorganization Plan No. 3 of 1970, and Public Law 86-373 to '...
advise the President with respect to radiation matters, directly
or indirectly affecting health, including guidance for all
Federal agencies in the formulation of radiation standards and
in the establishment and execution of programs of cooperation
with States.' This guidance has historically included both
qualitative and quantitative formulations. The recommendations
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we propose here would replace those portions of existing Federal
guidance that apply to radiation protection of workers, which
were adopted in 1960 (25 FR 4402)."
EPA prepares and submits to the President recommendations for new Federal
radiation:-protection guidance..- Upon his approval, these recommendations
become guidance to Federal agencies in the conduct of. their radiation
protection activities. Thus, it is not EPA, but the President who .
prescribes'-new guidance to--Federal agencies. This is the procedure
followed during and subsequent to the existence of the former Federal
"Radiation Council (FRC), whose functions were transferred to EPA by the
Executive Order cited above, under which the FRC was abolished. A
significant new feature.added by EPA to this procedure is that of
providing the opportunity for public participation in the formulation of
recommendations to the President.
1.11.39 The establishment of a value of person-rem would be the most
important contribution the EPA could make to the development of a system
of dose limitations (A.a-40).
Response: EPA has given some consideration to the appropriate value for
the unit of collection dose, person-rem, in a number of its rulemaking
activities. We recognize that the choice of an acceptable value could, in
some respects,.simplify the, regulatory process. However, in real
applications', 'different" values may be appropriate, and other
considerations are invariably also relevant to the choice of an
appropriate level of control. We have concluded that a fixed value for
this parameter is not achievable at the time.
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SECTION 2.0 SPECIFIC ISSUES
2.1 LOWER RPGs
'Z.ll'l-' The costs of' lowering the RPG'below 5 rems are not justified by
any substantial benefit ,(.A.b-20,. A.d-19, B.a-4, B.a-8, B.a-22, B.a-32,
B.c-22,'E.a-6).' ' ' . " '
Response: In .the final recommendations, the limit for the effective dose
equivalent is 5 rems, as in the proposed recommendations.
2.1.2 There is no scientific reason to set the annual limit below 5
rems (A.a-41, A..d-12, B.a-8).
Response: We disagree, since we assume a linear dose-effect relationship,
not a threshold relationship: However, the choice of an annual limit can
not be made solely on scientific grounds. See also the responses to
comments 1.4.6, 1.4.9, 1.4.10, 1.4.14, and 1.4.26.
2.1.3 The annual limits should not. be set below 5 rems (B.a-6, B.a-17,
'B.a-22, B.a-26, B.b-7,.' B.c-23,- D-4, E.a-5). ' -
Response: See the response to comment 2.1.1.
2.1.4 Setting the RPG below 5 rems is impractical, since some jobs
require exposures near 5-.rems (A.b-18, B.a-8, B.a-32).
Response: See the responses to comments 2.1.2 and 2.1.9.
2.1.5 A reduction in the annual limit below 5 rems would increase
collective dose and health effects (A.a-42, B.a-1, B.a-6, B.a-22, B.a-32,
B.a-33, B.a-48, E.a-6).
Response: We believe that this could occur only if the annual limit were
established below 3 rems, the current quarterly limit. The magnitude of
such counter-productive results would depend on how much lower than 3 rems
the annual limit were set.
2.1.6 A reduction of the RPG to 3 rems would result in costs for
equipment modifications, etc. A RPG less than 3 rems would impact the
operational capabilities of DOD (E.a-2).
Response: See the responses to comments 1.9.14, 2.1.1, 2.1.5, and 2.1.9.
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2.1.7 A reduction of the RPG to 0.5 rem/yr, 1 rem/yr, or 3 rem/yr would
result in an increase in the number of workers at a nuclear plant and the
associated costs would increase dramatically (B.a-48).
Response: See the responses to comments 2.1.1, 2.1.5, and 2.1.9
2'.1.'8 ' 'Limiting lifetime accumulated dose is a "more viable" approach
than reducing.annual dose limits (A.a-49, A.a-50, A.a-51, A.b-18).
Response: In part., we agree. However, because a large majority of
commenters and Federal agencies opposed a lifetime dose limit, the final
recommendations do not specify a limiting lifetime accumulated dose. See
also the response to comment 1.6.8. However, the final recommendations do
address the recording and minimization of cumulative lifetime individual
dose.
2.1.9 Since 97% of all workers surveyed received less than 1 rem/yr,
the limit of 5 rem/yr is unrealistically high (D-l).
Response: A number of commenters cited a need for a 5 rem/yr dose limit
rather than^a lower limit. In the nuclear power industry commenters
testified that a 5 rem annual limit is needed for a small number of highly
skilled workers doing such specialized work as steam generator repairs and
steam generator eddy current inspections (B.a-1, B.a-8, B.a-28, B.a-37).-
Westlnghouse testified their experience suggests a further need for
exposures above 5 rem/yr for a small number of skilled workers involved in
nuclear power plant service (B.a-46). They wrote: "Hiring or training
qualified replacement workers is difficult or impossible for many of the
complex skills and tasks involved ... that limits such as these would
severely restrict specialty workers to the point of making certain tasks
difficult or even impossible to perform (B.a-48)." The result of not
utilizing experienced workers is increased worker exposure and/or costs or
increased length of power outages (B.a-34, B.a-44, B.a-46, B.a-47,
B.a-49). In the medical profession, commenters said the limited number of
certain professionals, such as cardiologists, to conduct critical
procedures could lead to restrictions on the numbers of such procedures,
and that the current national manpower pool does not contain adequate
duplication of workers for certain skills (A.d-14). In addition to the
difficulty of obtaining qualified personnel, we estimated associated
annual costs to be on the order of several hundred million dollars for
hospitals for a limit of 1-2 rem/yr (EPA83a). A similar impact was
estimated for increased manpower, facility, and health physics costs in
some government research and development' programs (DOE80).
EPA assessed the impact for an annual limit of 1.5 rems. Although
risks to the highest exposed individuals would decrease, there is general
agreement that the overall risk or collective dose would increase, as
would costs for equipment and additional manpower. We estimated a total
increase of approximately 6000 person-rems and almost 30,000 workers would
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be required, at a first year cost of over $100 million and recurring
annual costs of &400-700 million (EPA83a, DOE80).
For the above reasons we concluded that there is a limited number
of situations -in which it may be justified for workers to receive annual
doses, up to. five rems. Consideration .of the 1'ow level of worker exposure
under current limits, and the large'costs and difficulty of worker
duplication' in these areas led us to conclude that there is sufficient
reason.to retain a 5 rem annual limit at this time.
2.1.10 The RPG should be set at 0.5 rem/yr (A.a-38, A.a-44, A.c-6,
A.c-8, C-6).
Response: See response to comments 2.1.5 and 2.1.9.
2.1.11 The annual dose limit should be 0.5. rem/yr, as 5 rem/yr does not
provide an acceptable level of risk (A.c-7).
Response: The level of risk to the average worker under a limit of
5 rem/yr is expected to be less than the risk of accidental death in
industries considered "safe" (ICRP77). The estimated average incremental
risk of premature death (approximately 2 to 5 in 100,000) for measurably
exposed (0.2'rem) U.S. .Workers in 1980. (Ku84) is comparable to the safest
industry group,' trades (averaged about-5 per 100,000 from 1980 to 1984),
and less than the Incremental risk of accidental death (11 per 100,000)
for all-industry workers in 1984 (NSC84). The maximum annual risk at
5 rem/yr is approximately 1 per 1,000 for premature death from radiogenic
cancer. The guidance further specifies that this annual risk should not
be incurred for a substantial portion of a working lifetime.
2.1.12 The dose limit to women should be 0.25 rem/yr (A.c-6).
Response: We disagree. There is insufficient difference between the
radiogenic risks to men and women to justify a lower limit for women,
except when pregnant and then for the protection of the unborn. For this
case, our recommendations provide for protection of the unborn child
without economic penalty or loss of job opportunity and security to women.
See also the responses to comments 1.4.1, 1.4.2, 1.4.9, 1.4.21, 1.4.22,
1.4.26 and 2.13.6.
2.1.13 The RPG should be 2.5 rem/yr, with a quarterly exposure limit at
25% of the annual RPG (C-5, C-7, C-8).
Response: See the responses to comments 2.1.2, 2.1.5 and 2.1.9.
2.1.14 The weighted sum of annual dose equivalents and committed dose
equivalents should be less than 1 rem (A.c-1, C-4).
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Response: See the responses to comments 2.1.2, 2.1.5 and 2.1.9
2.1.15 The annual whole-body dose limit should be 1 rem, with limits to
the gonads of 1 rem, to the'eye lens of 1 rem, to the hands of 30 rems,
and to any other organ of 15 rems (A.a-1, C-4).
Response: See the responses, to comments 2.1.2, 2.1.5 and 2.1.9.
2.1.16 The annual whole-body limit should be 1 rem, with limits to the
gonads of 1 rem, to the eye lens of 1 rem, to the hands of 10 rems, and to
any other organ of 6 rems (D-5).
Response: See the responses to comments 2.1.2, 2.1.5 and 2.1.9.
2.1.17 Given the proven hazard of radiation at all levels, there is no
justification for exposure beyond background levels (A.c-7, C-6).
Response: The possibility of risks from exposure at levels within the dose
limits is not, by itself, justification for shutting down all beneficial
activities that involve exposure to radiation. Most employment carries
some attendant risks, and in most cases the observed risks of accidental
death are comparable to or greater than those estimated for average occupa-
tional exposure to radiation. Also, see the response to comment 1.3.10.
2.1.18 The maximum permissible exposure to gonads and red marrow should
be reduced to 5 rem/yr (A.c-6).
Response: The final recommendations adopt the limits specified in
ICRP-26. These values were chosen so that all types of exposure are
limited to approximately the same level of risk. Also, see the responses
to comments 1.3.1 and 1.6.12.
2.1.19 Whole body occupational exposure limits should be 0.5 rem per
year and the population environmental exposure should be limited to 25
millirem per year (A.c-6).
Response: See the response to comment 2.1.9. The subject recommendations
are confined to occupational exposure. Other EPA standards (40 CFR 190
and 40 CFR 61) limit dose to members of the public to 25 millirem per year.
2.2 VALUES OF RPGs AND RIFs ONLY ALLOWED TO DECREASE
2.2.1 There is no sound technical basis for accepting only those ICRP
recommendations that produce more restrictive limits and selectively
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rejecting those that produce less restrictive limits (A.a-41, A.b-16,
A.b-18, A.d-9, A.d-12, A.d-15, B.a-6, B.a-7, B.a-9, B.a-17, B.a-23,
B.a-34, B.c-22,- E.a-5, E.a-6, E.b-2, E.b-3, E.b-9, F-2).
Response: We agree, in. general, and have deleted this provision. However,
the 'proposed recommendation was. based o.n the -assumption that conformance to
existing limits demonstrated tha-t such 'levels were achievable and "ALARA; "
therefore', no justification existed for use of higher values. In situ-
ations.'identical ,Tor. similar .to those in effect in the past this observation
would continue to be true and higher values should not be used, since the
final' recommendations' continue to require that ALARA be practiced.
2.2.2 Part b of Recommendation No. 5 has no justifiable basis other
than the Agency's reluctance to change to less restrictive values, and
should be deleted (A.a-41, A.d-19, A.d-21, A.d-40, B.a-13, B.a-27, B.a-32,
B.a-34, B.a-46, B.a-48, B.c-12, B.c-21).
Response: See the response to comment 2.2.1.
2.2.3 In order to- properly allocate radiation protection resources
based on- risk, limits should be raised and lowered as the evidence
suggests (A.b-15, A.b-20, A.d-23, B.a-8, B.a-17, B.c-10, E.a-6, E.b-8).
Response.:' We agree. See, however, the responses to comments 2.2.1 and
2.2.8' -..--.... . ' - .
2.2.4 The policy that limits be no higher than currently in use will
result in confusion among radiation protection professionals (A.a-6,
E.arS, E.b-8)..
Response: The final recommendations do not contain such a provision.
2.2.5 The refusal to increase an RIF despite the indication to do so
tends to discourage research, since results that lead to an increased RIF
would be ignored (E.b-2).
Response: We do not agree. However, see the responses to comments 2.2.1
and '2.2.8.
2.2.6 Reducing guides to levels that have been shown to be possible
will reduce the incentives to maintain exposures ALARA (B.a-29, E.b-8).
Response: We disagree. However, see the response to comment 2.2.1.
2.2.7 The ALARA criterion and not the arbitrary lowering of limits if
they can be achieved, should be used to reduce risk (E.a-6, E.b-5, E.b-10)
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Response: We agree. See the response to comment 2.2.1.
2.2.8 To raise the MFCs merely because it can .be done without
surpassing the. whole body annual dose equivalent is contrary to the basic
objective of radiation protection; keeping- a-11 .exposures ALARA (C-l).
Response:- The MFCs and the ALARA principle serve two different
functions. , The. MFCs correspond, for normal circumstances, to the limit on
maximum committed dose- The ALARA principle requires that doses be
maintained as far below that limit as reasonably achievable. The
importance of maintaining exposures ALARA is emphasized in the
recommendations. Under the ALARA principle, the calculational increase of
a regulatory MFC value, per se, is not sufficient justification for then
allowing the increase of an individual's exposure. See also the response
to comment 2.2.1.
2.2.9 Recommendation 5b suggests that errors in the past should be
promulgated into the future (A.a-40, A.a-49, A.a-50, A.a-51, A.b-18).
Response: -This is incorrect. The proposal was based on the assumption
that past practice demonstrated that the previous levels were reasonably
achievable. However, see the response to comment 2.2.1.
.2.2.10 Recommendation 5b applies ALARA separately to each radionuclide,
virtually guaranteeing a misallocat'ion of resources (E.b-2).
Response: See the response to comment 2.2.3.
2.2.11 'The real harm of constantly "ratcheting" limits is the
inisimpression given to the general public; namely, "If there isn't any
harm in radiation exposure, why are the limits constantly being lowered"
(A.a-41)?
Response: Although it is a basic assumption that some harm is associated
with any radiation exposure, we did not use the "ratcheting" approach.
Under the system of dose limitation adopted in our final recommendations,
some of the new derived limits are higher and others lower than in
existing guidance. These recommendations, as well as those of ICRP, NCRP,
etc., are based on the belief that there are risks involved in exposures
at any level, even at the levels within recommended limits. The limits
are not to be considered a division between "safe" and "unsafe" levels-
See also the responses to comments 1.6.11 and 2.2.1.
2.2.12 If EPA feels unable to increase limits, the lower values should
be listed as an advisory list that EPA believes can be met in the cause of
ALARA (A.b-16).
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Response: -See the responses co comments 2.2.1 and 2.2.8.
2.2.13 We agree with EPA-that the ICRP recommendation should only be
adopted- in situations where current exposures are maintained or reduced
(C-2, C-6,.E
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recording lifetime doses to establish recordkeeping requirements that will
help to minimize abuse of temporary workers.
2.3.2 Transient workers require special protection since they do not
admit their, exposure at previous plants,, are not well educated, have small
regard for the.risks, .and frequently are in such a financial position that
if and when they develop radiation-related cancer their children become a
financial burden- to society (A.a-5)-
Response: Workers who are able to circumvent the rules and regulations
designed to implement dose limits present a difficult problem. The new
requirements for instruction on risks (including information on the
specific risks of their jobs) and for recording of lifetime dose may lead
to rules that will reduce such occurrences. It would be ideal to provide
protection for even those who, for whatever reason, wish to ignore or
circumvent regulatory dose limitations. See also the response to comment
2.3.1.
2.3.3'- A partial solution to the abuse of transient workers is to
redesign reactors and improve shielding to minimize high dose maintenance
jobs (A.c-6).
Response: Substantial efforts have been and are being made to keep
exposures of both transient and regular.workers ALARA; these include
engineering efforts.. See also the response to comment 2.3.1.
2.3.4 EPA & NRC underestimate the number of transient workers and the
doses they are receiving, and these workers may not be fully informed of
the hazards of radiation (A.b-21).
Response: The EPA reports on occupational exposure in 1975 and 1980 do
not contain separate statistics on "transient workers" (CobSO, Ku84).
Such workers at nuclear power plants are included in the statistics for
all workers in the Nuclear Fuel Cycle category in these reports. The NRC
has regulations designed to provide the same protection to all these
workers and to provide instruction on the risks of exposure to radiation.
Under NRC regulations, the dose record of any worker at a nuclear power
station is submitted to NRC each time he terminates employment at a given
station. These records are maintained by NRC. See also the response to
comments 2.3.1 and 2.3.2.
2.3.5 EPA has not assessed the impact of its guidance on the highly
skilled, but limited pool of transient workers. The guidance would limit
the use of these workers, thus increasing total radiation exposure of the
workforce (B.a-46).
Response: Although we have not carried out an independent study on this
matter, we have analyzed the reports of others, including those of the
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Atomic Industrial Forum (AIF80, AIF84). We conclude that the change of
the basic'limit from 3 rems per quarter to 5 rems per year, will have no
significant adverse effect (if any) on either the highly skilled transient
workers or on collective dose. If any new workers must be trained to
avoid exposures greater than 5 rem. per year, the guidance recognizes the
..need for. an appropriate .period, of time for implementation. See also the
responses to .comments 1.9.5, 1.11.14 and 2.1.5.
..' t
'2.3'.6 ' A'dose limit should be established beyond which documentation of
a transient worker's year-to-date exposure record must be obtained
.(A.a-19, A.b-21).
Response: Appropriate monitoring, maintenance of a cumulative record, and
availability of the workers exposure record on an annual basis are
addressed in the final recommendations. However, detailed implementation
must be based on procedures specified in regulations by the cognizant
Federal agency.
2.3.7-. The-, current regulations are sufficient to protect transient
worker's (E.a-5).
Response': Without commenting on the validity of this comment, it should
be. noted that we believe the new recommendations will lead to improved
protection to all workers, including transient workers.
2.3.8 . NRC, not EPA, should develop strict regulations to cover
non-nuclear utility station employees assigned to temporary nuclear duties
(A.c-6).
Response: We agree that NRC is the agency responsible for detailed
regulations concerning all workers, permanent and temporary, at nuclear
power plants. EPA is charged to advise the President on appropriate
recommendations to Federal agencies applicable to the protection of all
workers; it does not directly regulate worker exposures to ionizing
radiation.
2.3.9 The occupational exposure data base used by EPA is questionable,
since personnel monitor readings misrepresent whole body doses (A.b-15,
A.d-22, A.d-28).
Response: The significance and possible shortcomings of the data used by
EPA to derive exposure statistics are discussed in our occupational
exposure reports [EPA 520/4-80-001 (CobSO) and EPA 520/1-84-005 (Ku84)].
For example, "A monitoring device only records the dose it receives...the
recorded dose may or may not approximate...whole-body dose" (CobSO). We
believe, however, that these possible shortcomings do not affect the
recommendations.
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2.3.10 By using the arithmetic mean to indicate the average worker's
exposure, EPA has overestimated occupationally-related radiation risk
.(A.b-1). . .
Response: We disagree. EPA Reports No. 520/4-81-003 (EPA81) and
No. 520./.4-80-001 (GobSO) .cont.ain 4!! essential data, .including dose
distributions, and explain in detail the methods used in the
computations. .For'.estimating' radi'ation risks, the statistic of "average"
.(arithmetic mean) dose is the relevant quantity for estimating the
detriment in a'group of known size.
The problem may be one of semantics. We have defined the term
"mean" annual dose to be the collective dose of all potentially exposed
workers divided by that number of workers. This may not be equivalent to
the "average worker" referred to by the commenter.
2.3.11 In some risk comparisons, EPA averages in unexposed workers to
make the mean worker exposure appear lower (A.a-3).
Response: We 'believe-we presented a clear', objective, and meaningful
analysis of worker-risks. These risks-were given both for "all
potentially exposed" workers and for just those workers "measurably
exposed." See also the response to comment 2.3.10.
2.3.12 The occupational exposure data base is inadequate, as monitoring
in many occupation's is nonexistent while in others it is not universal;
until badging is universal EPA should err on the side of safety (A.a-5).
Response: There are, indeed, many difficulties in making comprehensive
radiation .exposure analyses of occupational exposures in the United
States. These are- discussed for the period from 1960 to 1980 in our
reports EPA 520/4-80-001 (CobSO) and EPA 520/1-84-005 (Ku84). Although we
expect to make continued improvements in future analyses, we believe a
careful reading of these reports will show that the exposure of workers is
adequately assessed for the purposes of risk assessment.
2.3.13 EPA should update its information base before decisions on this
guidance are made final, since it does not reflect 6 years of ALARA
redu'ctions and occupational exposures since 1975 (B.a-1, B.a-29).
Response: We have done so. Recently we completed a comprehensive
reanalysis of occupational exposure for the period 1960 to 1980 and made
projections for the year 1985 (EPA 520/1-84-005). The results of these
analyses do not differ significantly enough from the earlier analysis
(EPA 520/4-80-001) to warrant changes in the proposed guidance.
2.3.14 EPA overstates the number of radiation workers in medicine
(A.b-4).
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Response: In our report covering 1980 exposure, we use improved methods
for estimating the number of workers in medicine (Ku84). These estimates
indicate there are 584,000 potentially exposed workers in medicine, which
comprise approximately 44 percent of the potential exposed work force in
this country; corresponding figures in the report for 1975 exposures were
546,300 persons arid 49 percent .(CpbSO).. Revised estimates for 1975 are
485,000 persons and 44'percent (Ku84), which indicate our original
estimates (CobSO)' were only slightly high.
2.3.15 Since the data base on dose to medical radiation workers 'is
deficient, it is difficult to analyze the effectiveness of the proposed
minimum radiation protection requirements (A.d-8).
Response: The proposed minimum radiation protection requirements do not
appear as such in final recommendations. In the final guidance, general
recommendations are used to carry out the objectives of those proposals.
2.3.16 All nuclear licensees should obtain and take account of
cumulative radiation .doses of temporary workers before exposing them to
more radioactivity (A.c-6). . .
Response: The final recommendations encourage maintenance of a cumulative
record of lifetime.occupational.dose. However, such procedures are
specified, irr regulations and -regulatory guides of the Federal agencies,'
such as -NRG.
2.4 OMISSION OF MEDICAL AND OTHER NON-OCCUPATIONAL EXPOSURES
2.4.1 EPA should include guidance on medical exposures (A.a-12, A.c-8,
A.d-8, B.a-35).
Response: Radiation exposure of all workers, including medical workers,
is covered by this radiation protection guidance for occupational
exposure. But "occupational exposure" does not include exposure received
as a patient. Medical exposure of patients to diagnostic x rays is the
subject of separate EPA recommendations for Federal radiation protection
guidance (43 FR 4377), approved by the President on February 1, 1978.
2.4.2 EPA's omission of guidance for medical exposures can only be the
result of political expediency (A.b-8).
Response: See the response to comment 2.4.1 above.
2.4.3 If EPA's concern for somatic and genetic effects in radiation
workers is real, diagnostic medical exposures must be controlled.
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Physicians cannot make risk-benefit judgments, as they have no idea what
occupational exposures their patients receive (B.c-21).
Response: EPA is concerned about all unnecessary exposure to radiation.
However, occupational exposure usually has no bearing on whether or not a
medical expo.sure is justified.. The, decision for each medical exposure
should be based on its own individual merits, without'regard to occupa-
tional exposures. ' (A" possible exception may occur when the non-stochastic
limits are exceeded.) - . .
2.4.4 EPA should require medical practitioners to provide patients with
doses for each medical exposure. Such information is essential for
intelligent career planning (A.a-8).
Response: EPA does not have the authority to require medical practitioners
to provide patients with a statement of the dose received in each medical
exposure. See also the response to comment 2.4.3.
2.4.5 EPA should require informed consent prior to radiologic or
nuclear medicine procedures. This would eliminate unnecessary procedures
and reduce exposure to patient and worker populations. '(A.c-8, A.d-8).
Response: This comment is. outside the scope of this rulemaking on
occupational exposure to ionizing radiation. ' '
2.4.6 Epidemiological studies require records showing both occupational
and medical exposures (A.a8, C-5).
Response: We agree that this would .provide the most meaningful results,
all other applicable' requirements for such studies also being met.
2.4.7 The EPA should outlaw dangerous.practices in health institutions,
such as holding of patients during x rays, that cause radiation exposures
of workers (A.c-8).
Response: To the extent that such practice represents unnecessary
exposure of workers, it should be avoided. The ALARA provision of Federal
radiation protection guidance directs that such unnecessary exposure
should not occurt However, it is the responsibility of regulatory
agencies, not EPA, to assure that ALARA practices are followed.
2.4.8 The Federal Radiation Guides should require the identification of
radioactive patients and require standard care plans to protect medical
personnel caring for such patients (A.c-8).
Response: Such requirements would be useful for the achievement of ALARA
exposures. However, the suggested requirements are most appropriately
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promulgated by Federal and State regulatory authorities in their
regulations and guides, since these requirements are of a detailed nature
not normally addressed by Federal guidance.
.2.4.9 ' Adequate shielding, of patients and medical workers should be
mandatory (A.c-8).. . , ' " . . .
Response:" See' the "responses to comments 2'.4.1, 2.4.7 and 2.4.8.
2.4.10 EPA should provide guidance for x-ray exposures that would keep
doses as low as reasonable achievable, and forbid diagnostic x rays unless
other diagnostic procedures indicate such x rays will be useful (A.a-5,
A.c-6).
Response: ' See the responses to comments 2.4.1 and 2.4.11.
2.4.11 The EPA should recommend against routine pre-employment and
annual x'.rays for employment screening' purposes (A.c-6, A.c-8).
Response: EPA has done so in its Federal radiation protection guidance
for diagnostic x rays (43 FR 4377; February 1, 1978).
2.4.12' Medical exposures should be treated separately (A.b-10, A.b17,
A.b-26, A.d-13, A.d-22, B.a-20,*B.c-23).
Response: They are. See the responses to comments 2.4.1 and 2.4.3.
2.4.13 The guidance proposed by EPA should include consideration of
variations in natural radiation levels and the many activities that can
technically enhance the natural radiation background (A.a-10).
Response: Under the caption, "Other Considerations,".in the preamble to
our proposed recommendations (46 FR 7836) we state:
"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. Regulatory
agencies will have to use care in selecting.classes of workers whose
exposure does not need to be regulated. In selecting such classes we
recommend that the agency consider both the collective dose which is
likely to be avoided through regulation and the maximum individual
doses possible."
We recognize" that there are wide variations in normal background
radiation. See the response to comment 1.4.49. Doses received by workers
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from-such radiation are not considered "occupational," under Federal
guidance. However, a variety of working environments can involve
"technically enhanced natural radiation" levels. Although the radiation
involved is "naturally occurring," workers may have the potential for
.receiving significantly more than normal background exposure as a result
of- their occupation and -therefore it is-considered "occupational
exposure.,'.' For' certain activities, such as uranium mining and milling,
this is'recognized as such and worker-exposure is controlled accordingly.
In.-other.activitiesf .such as-air .transportation, some exposure of workers
occurs but it may or may not warrant regulatory control.
2.4.14 The EPA should release the research information and data pertinent
to occupational exposures caused by radon decay products in new energy
efficient buildings so that all significant exposure sources of occupation-
al exposure can be examined in evaluating the proposed guidance (B.c-1).
Response: This involves an issue (radon decay products) that is not
addressed by the proposed guidance. However, EPA continues to gather
information, sponsor studies, and publish reports related to such exposure
as suggested by the -comment. Although 'such exposure can be characterized
as technologically enhanced, it is more properly considered as a generic
issue involving .the entire U..S. population when indoors, regardless of the
location of a workplace or home. .See also the response to comment 2.4.13.
2.4.15 EPA should withdraw the proposed guidance and concentrate on-the
much larger and more dangerous problem of indoor radon exposures (A.a-9).
Response: The Agency has proceeded with the formulation of final
recommendations for new Federal radiation protection guidance for
occupational exposurebecause, we believe it is.needed and will benefit
workers. However, we agree that indoor radon exposure is a major public
health issue, and EPA is conducting, in concert with other Federal
agencies, a careful study of this problem and its solutions.
2.4.16 Rather than set extremely rigorous standards for indoor radon
exposures, EPA should relax the recommended guidance to reflect the
growing, consensus that exposures to low-LET ionizing radiation at low dose
rates are less hazardous than previously assumed (A.a-9).
Response: Standards for indoor radon exposures are not a part of the new
recommendations for occupational exposure (See the response to comment
2.1.14). As indicated in its background report, EPA makes use of the best
available scientific information on the biological effects of ionizing
radiation. This information includes consideration of low-LET ionizing
radiation at low dose rates (See the response to comment 1.4.1).
2.4.17 Persons incidentally exposed, i.e., the general public, should
also be protected by guidelines (A.d-13).
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Response: They are. As stated in the preamble to the proposed
recommendations (46 FR 7836), the new recommendations "would replace those
portions of existing Federal guidance that apply to radiation protection
of workers,- which were adopted in 1960 (25 FR 4402)." Thus existing
guidance for the protection of the general public would continue in force.
2.5 ... - .OMISSION.OF UNDERGROUND MINERS AND OTHER OCCUPATIONAL CATEGORIES
2.5.1 EPA should reconcile its recommendations with the Mine Safety and
Health Administration (E.a-3).
Response: A close liaison is maintained between EPA and the Mine Safety
and Health Administration (MSHA). MSHA is a member of the interagency
working group'formed by EPA to develop this Federal radiation protection
guidance for occupational exposure, and has concurred in the final
recommendations.
2.5.2 EPA should take note, particularly of highly damaging-alpha
radiation released in uranium mines, that doses to uranium miners are
calculated from air concentrations measured at regular intervals in mines
but which do .not. account.for. high individual doses (A.c-6).
Response:- It is the responsibility of regulatory agencies to require
types and frequency of measurements appropriate to assuring that
individual workers do not exceed the limit specified by Federal guidance.
We note, however, that existing Federal guidance for radon decay products
is not changed by the subject guidance. See also the response to comment
2.5.3.- ...
2.5.3 EPA should establish a RIF for uranium miners (in terms of rems)
consistent with the RIF's for other categories of nuclear workers (C-5).
Response: The existing guide (36 FR 12921) for limiting exposure of
underground miners to radon decay products is not changed by the final
recommendations for Federal radiation protection guidance for occupational
exposure. We intend, however, to review that guidance in the near
future. In the meantime exposure of miners to radiation other than from
intake of radon decay products is governed by the new recommendations.
2.5.4 EPA should review the guide for exposure of uranium mine workers
as there may be serious adverse health effects at levels formerly
considered relatively safe (A.b-9).
Response: As stated in the preamble of our proposed guidance (46 FR
7836), "We expect to review the guide (36 FR 12921) on exposure of miners
to decay products of radon in the future."
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2;5.5 What radiation protection guide applies to non-uranium miners.
exposure to radon decay products and how does it compare to the uranium
miners' guide (A.a-10)? ...
Response: .Although the Federal guide (36 FR 12921) for radon decay
products (4. WLM/yr) addressees "underground uranium miners,." it is applied
by regulatory agencies (e.g., MSHA, NRG) to other classes of miners, and
workers in other employment activities, for which that guide is
appropriate.. ...........
2.5.6 EPA should consider the doses received by non-radiation workers
in industries such as phosphates, fertilizers and the airlines (A.b-4).
Response: EPA was cognizant of exposures received by such groups of
workers (Co80, Ku84) in the phosphate (EPA76), fertilizer (EPA76) and the
airline (EPA74) industries, as part of the background information used in
developing new recommendations for Federal guidance on occupational
exposure. See the response to comment 2.4.13.
2.5.7 EPA should not allow transportation workers to receive radiation
exposures higher than the general public (A.c-6).
Response: . Many.transportation workers are already protected to the same
''level as members of the public. There are, however, transportation
workers engaged wholly or significantly in the transportation of
radioactive materials who may receive higher doses. EPA is not the'
appropriate agency to decide that a lower dose limit should apply rather
than the maximum permitted other workers. However, Federal radiation
protection guidance provides the basis for such regulations by the
regulatory agencies (DOT, NRCj etc.) when they are appropriate for the
protection of such workers.
2.6 OMISSION OF EMERGENCY EXPOSURES
2.6.1 Setting guidelines for accidental or emergency exposures serves
no purpose as such exposures are, by definition, uncontrolled (B.c-23).
Response: While it is true that accidental exposures are uncontrolled,
the same is not true for "emergency exposures." Emergency .exposures are
controlled exposures involving doses above the established limits received
by workers in assignments of an emergency nature, such as a lifesaving
operation.
2.6.2 Emergency exposures should be addressed in the recommendations
(A.a-18, A.a-19, A.d-9, A.d-22, B.a-20, B.a-32, C-22, E.a-5).
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Response: .Recommendation 10, which addresses emergency exposures, does
not include specific limits. This matter is left to the Federal agencies,
to be determined on the basis of the general guidance provided, because
they are most-knowledgeable about, the specific situations under their
jurisdiction in which emergencies.may occur;
2.6.3 .-Emergency guidance should include the recommendations of the NCRP
and the. application of ALARA. (A.a-8)..
Response: Recommendation 2 (which addresses ALARA) applies to all types
of controlled exposures, including emergency exposures. See also the
response to comment 2.6.2.
2.6.4 The only way to eliminate "Higher Than Normal" doses is to
eliminate accident and inci'dent prone situations. Exposures can be
minimized through employee education (A.a-5).
Response: While we agree in general, it should be noted that
higher-than-norma-1 doses are not confined to accidents and emergency
situations. There are unusual circumstances (e.g., astronaut missions)
for which- it may be necessary to permit doses higher than the limits.
These situations are covered by Recommendation 10. Also, see the response
to comment 2.6.3.
2.7 IMPACT OF RPGs ON COLLECTIVE DOSE
2.7.1. A reduction in the individual dose limit will result in an
increase in collective dose (A.a-19, A.a-42, A.d-31, B.a-1, B.a-2, B.a-3,
B.a-17, B.a-21, B.a-38, B.a-39, B.a-46, B.a-54, C-2, D-6, D-ll, E.a-5,
.E.b-6, E.b-8, E.b-10).
Response: There is a possibility for this to occur, depending on the
extent to which the dose limit is reduced. We gave this matter serious
consideration and concluded that the dose limits chosen in the final
recommendations would not lead to an increase in the collective dose to
the work force. See the response to comment 2.1.5.
2.7.2 Guidance should be provided on how to weigh the benefits of
decreased individual exposure against the costs of increased population
exposure (A.a-42, B.a-1, B.b-5, D-6, E.b-10).
Response: We know of no single method for determining trade-offs between
the reductions in dose to an individual and in collective dose that would
be applicable to all cases. Rational decisions on trade-offs between
individual and collective doses can only be made on a case-by-case basis,
and may, in rare cases, have to be arbitrary.
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2.7.3 . EPA should clarify its position on ALARA individual vs. ALARA
collective doses .and revise the guidance accordingly (A.d-40, B.a-54).
Response: See the response to comment 2.7.2.
2.7.4 '. Since only. trained persons are used, collective dose will not
increase when rotation of workers is- used to reduce individual doses
Response: We agree that this is generally true, and employers should
ensure that only properly trained workers are used. However, the extent
of unavoidable unproductive exposure (such as that during entry to and
exit from high radiation areas) can be relevant in high dose rate
situations. While there is the possibility of an increase in the
collective dose in such operations, we do not believe that the final
recommendations will lead to. increasing the collective dose in the work
force due to increase in such exposure, because the limit applicable to
any single job has not been decreased. (In fact, it has been increased:
the 'effective previous limit applicable to such situations was 3 rems ; the
new effective limit is 5 rems.-) See also the responses to comments 1.9.5
and 2.3.5.
2.7.5 . Collective dose is less' significant than individual dose; the
primary risk is-to the worker and his family (C-8).
* .
Response: This depends upon the point of view that is relevant to the
judgment. However, EPA believes that both types of doses have
significance and therefore are addressed by the final recommendations.
From a national point of view the total detriment, which is related to the
collective dose, is most- significant. From the point of view of
sufficiently limiting the risk to each worker, the maximum individual dose
is most significant.
2.7.6 The consequent increase in collective dose resulting from the
guidelines will lead to an increase in potential health effects (A.a-42,
A.b-4, A.d-5, A.d-14, B.a-17, B.a-18, B.a-46).
Response: We do not believe these recommendations will result in any
increase in collective dose to the work force. See the responses to
comments 2.7.1 and 2.7.4.
2.7.7 Lowering the individual RPG implies that engineering controls
must be improved to keep collective doses from rising (C-5).
Response: We disagree. See also the responses to comments 2.7.4, 2.11.1,
2.11.3 and 2.11.4.
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2.8 CONSIDERATION OF WORKER AGE
2.8.1 Age is also an important factor in determining risk. EPA's
guidance should consider age in justifying the proposed lifetime limit
(IUa-46)'. ... /- . . . . .........
Response: We agree that age is an important factor in estimating risk.
However, because of overwhelming opposition in public comments, the
admonishment or objective to manage workers so that their lifetime
accumulated dose is less than 100 rems does not appear in the final
recommendations.
2.8.2 Setting reduced exposure limits for young workers creates two
inconsistencies: first, the majority of the high exposure jobs are
physically strenuous and require younger workers, and second, older
workers are typically given more frequent physical exams to detect
physical limitations (E.b-8).
Response: The recommendations do not differentiate younger from older
workers, except 'in the case of minors. The lower dose limit far minors
(workers younger than 18) is consistent with previous guidance and
longstanding custom that underage persons should be given greater
.protection.against occupational hazards than adult workers.
2.8.3 EPA should include the age factor in its guidance (A.a-38,
A.a-46).
Response: We recognize that the risk from exposure generally appears to
decrease with age. However, age-dependent limits discriminate against
younger workers. They would also be'difficult to administer. We have
concluded that it is not practical to limit doses to workers on the basis
of an assumed age-dependence of risk, given the present state of
knowledge. See also the response to comment 2.8.5.
2.8.4 Consideration of worker age will only result in additional work
and lack of acceptance by both labor and management (A.d-22).
Response: We have no comment on this opinion.
2.8.5 EPA should not include a higher limit for older workers since
specific health .problems may put them at higher risk (A.b-26).
Response: We are not aware of any scientific support for the thesis that
such workers are at higher radiation risk. However, the dose limits in
both our proposed and final recommendations are age-independent.
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2.8.6 The possibility of increased cancer risk from radiation in both
younger and older workers compared to middle-aged workers should.be
explored (A.c-6).
Response: EPA consideredthe available data on age dependence of risk.
This information is further updated and discussed in the responses to
comments given in subsection 1.4.
2.8.7 The'genetic risks do not justify setting age-dependent dose
limits (B.'.a-42). .
Response: The limits recommended are intended to protect against both
somatic and genetic risks. However, the recommendation of an age-indepen-
dent limit does not imply that we consider genetic risks to be negligible.
2.8.8 Since older workers are.more experienced and generally can do
difficult jobs which might involve higher exposures more efficiently than
less experienced younger workers, a scheme allowing older workers higher
dose increments in any time period would probably result in a lower total
workforce exposure (A.a-38).
Response: The recommendations permit this type of strategy to be
followed., provided the. overall annual limiting doses are adhered to and
continued exposure-of'a worker at or near annual limiting doses for
substantial portions of a working lifetime is avoided.
2.9 NEGLECT OF PROCEDURES FOR OVEREXPOSURES
2.9.1 ICRP recommendations for handling overexposures should be
included in the guidance to allow needed flexibility (A.d-13, B.a-46,
B.a-48).
Response: The recommendations do not address overexposures with respect
to the limiting values for annual dose, since we believe this is a matter
properly addressed by regulatory authorities. (However, for the case of
failure to satisfy the recommendations for control of committed dose due
to intake of radioactivity, there is follow-up management of a worker's
future exposure. That is, when conditions for control of intake of
radioactive materials have not been met, the recommendations provide that
annual dose equivalents from such intakes should be assessed for as long
as they are significant for ensuring conformance with the limiting values
for effective dose equivalent in any year.)
2.9.2 Situations requiring larger doses should have been part of the
guidance (A.d-22, A.d-24, B.a-46, B.a-48).
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Response: Recommendation 10 provides for such unusual circumstances.
2.9.3 . EPA should clarify the consequences to both the worker and the
employer, when an RPG is exceeded (A.b-15, A.d-21).
Response: These matters, by law, are determined by' the cognizant
regulatory' agencies,, not EPA- .
2.9.4 EPA must provide guidance for reporting and evaluating
overexposure incidents and prescribe and enforce penalties that will
induce industry to limit worker exposures to within the proposed limits
(C-6).
Response: See the response to comment 2.9.3.
2.9.5 Failure to provide for overexposures may result in serious
distortions of the significance of minor overexposures (in the range of
6-10 rems)-and lead to emotional trauma- for the worker and other
undesirable over-reactions (A.b-13).
Response: We disagree that such overexposures should be considered
minor. In any case,, the risks from such exposure can be evaluated. This
evaluation should be made available to the worker to avoid inappropriate
.reactions.
2.10 ADEQUACY/ACCURACY OF DOSE MEASUREMENT TECHNOLOGY
2.10.1 Internal dosimetry techniques are not, in general, sufficiently
sensitive or sophisticated to provide the data required by ICRP's concept
of weighting factors for organ doses from internal emitters. The 50-year
annual committed dose equivalent concept only compounds the difficulty,
effectively reducing the RIF for long-lived biologically persistent
isotopes by a factor of 50 (A.d-12, A.d-15, B.a-24, E.a-5, E.b-3, E.b-6).
Response: The comment is based upon an apparent misconception of the use
of weighting factors. It is not necessary that dose to each of the organs
of a worker be measured for internal emitters. Instead, the total intake
is measured (or inferred from workplace conditions) and models specified
by ICRP-30 (or their equivalent) are used to calculate the effective (i.e.1
weighted) dose. Detailed'tables already exist (ICRP80) for this purpose.
Thus, the estimation of dose is, in effect, identical in procedure to that
now employed for determination of conformance to the existing limits based
on the Maximum Permissible Concentrations (MPCs). The assertion that the
RIF is effectively reduced by a factor of 50 over the MPCs for long-lived
radioisotopes is incorrect. Current MPCs are based on a similar concept
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involving the assumption of 50 years of intake, and yield identical values
for equivalent' metabolic .and internal distribution models.
2.10.2 In Vivo counting, .in some cases, cannot- establish that EPA's
required RIF.'s'are opt being exceeded (E.b-5, E.b-6)..
Response: See the response to comment 2.10.1.
2.10.3 Neither personnel dosimeters nor air monitors are sensitive
enough to detect exposures at the levels provided for in the guides
(A.c-6, B.a-24, E.a-5, E.a-7).
Response: We disagree. See the responses to comments 2.10.1, 2.10.4, and
2.10.5.
2.10.4 The 50-year dose commitment requirement will require greatly
improved surveillance methods and greatly- increased bioassay frequencies
(E.a-5, E.a-7,;: E.b-6). . '
Response: This is not the case. The existing regulatory requirements are
based on models that are mathematically identical or equivalent to the
50-year dose commitment. That is, the old MFC and the new DAC values are
based on the 'same -50-year dose commitment requirement. Thus, the new
guidance imposes no new burden. The sometime* large changes in these
values are primarily the result of improved dosimetric a~nd metabolic
models (EPA84b), not changes in the limits. See the responses to comments
1.6.12 and 2.10.1.
2.10.5 Low-level chronic uptake of internal emitters makes it virtually
impossible to determine what fraction of the material in the body organs'
is attributable, to the current year's intake (E.6-3).
Response: Such difficulties are not new to these recommendations.
However, health physicists have been able to -deal with them in the past,
and we expect that they will continue to be able to do so. See also the
responses to comments 2.10.1 and 2.10.4.
2.10.6 Personnel dosimetry is not accurate for extremity exposures. If
limits to extremities are unnecessarily reduced, more frequent and
accurate measurements will be needed and applied health physicists will be
faced with the task of interpreting the actual dose from a multiplicity of
conflicting data (E.b-8).
Response: Final recommendations adopt the dose limitations in ICRP-26, in
which the annual limiting-dose to the extremities (hands and forearms,
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feet and ankles) is 50 rems. This limiting annual dose of 50 reins, is only
marginally lower than the 75 rem limit in previous guidance (25 F.R.
4402). We believe there will be no difficulty arising from this modest
reduction. .
2.i'0*i7" EPA should'delay .implementing its' proposed guidance until a
detailed-analysis of dosimetry and internal measurement methods are shown
to be practical (E.a-7):
Response: We do not believe this is required. See the responses to
comments 2.10.1, 2.10.4, 2.10.5, and 2.10.6-
2.10.8 The ICRP scheme of weighted whole body equivalents for organ
doses ignores the lack of data on factors such as chemical species,
physical form, and route or intake that affect the movement and fate of
radionuclides taken into the body. Thus, the amount in a given organ
cannot be easily deduced (E.b-3).
Response: Values of the ALIs (and DACs) are available in ICRP-30 for
different chemical species, physical forms, and route of intake.
Additional values may .be computed for special cases using the models
' provided of' by developing, in rare cases, new models, as has been th.e
practice,in the past. See also the responses to comments 2.10.1 and
2.10.4. .
2.10.9 Accurate dosimetry monitoring is essential if recordkeeping and
remedial actions based on recordkeeping are to have credibility. Current
dosimeter processing techniques are so variable that performance standards
are necessary (C-5)
Response: We agree to the desirability of'performance standards for
dosimetry processing. Actions are already underway, by the Federal
agencies, for assuring the reliable processing of personnel dosimeters for
external radiation (NRC84). .
2.10.10 In the physical conditions at a nuclear station, the current
badge system in conjunction with area surveys is as' good as c;an and need
be .achieved (A.a-46, A.b.4).
Response: We concur, in general, although improved measurements may be
required in a few situations where intake of radioactive materials is
possible.
2.10.11 Film badges are not an accurate measure of actual exposure, but
interpretation can make the readings meaningful (C-8).
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Response: We agree that appropriate interpretation of film badge readings
is needed to determine the meaning of the actual exposure measured.
Obviously the type and energy of the radiation are important
considerations for determining deep dose and shallow dose, as defined by
the ICRU (ICRU76). In some cases the exposure of, worker to beam vs
isotropic radiation situations is important to proper estimates of dose.
See the'-response to- comment 2.3.9. ' . . .
2.10.12 Film badge readings do not reflect actual exposure, but are
useful as moving environmental monitors for design purposes (A.a-46,
A.b-4).
Response: We disagree. However, film badge readings do require proper
interpretation. See response to comment 2.10.11.
2.10.13 EPA's cho.ice of committed dose equivalent as a primary control
will not afford any greater worker protection. The effort required to
implement the required air monitoring system could be better spent on
other'protection activities (E.b-6).
Response:;. ,We...do-not believe, it is appropriate to relax the currently used
system for controlling internal exposure, which is equivalent to the new
recommendation based on committed dose equivalent. See the response to
comment 2.10.1.
2.10.14 EPA's guidance (proposed Recommendation 5) calls for establishing
committed dose equivalent on the basis of intake data. This method gives
a less accurate.indication of internal dose than the current practices of
whole body counting and urinalysis (A.d-13).
Response: The recommendations do not specify whether compliance should be
assessed based on exposure or intake. The use of derived limits such as
the. DAC is a generally accepted practical means for control of anticipated
dose. However, we agree that, when significant doses are involved,
accurate establishment of committed dose equivalent requires assessment of
actual uptakes via whole-body counting or urine/fecal analysis
methodologies. See the responses to comments 2.10.1 and 2.10.8.
2.10.15 Personnel dosimeters do not measure whole or partial body
radiation doses or organ doses. They are merely assumed to do so, despite
the overestimation, for administrative purposes. To use data derived from
these inaccurate devices as a basis for assessing noncompliance penalties
or as a basis of legal action is untenable (A.d-13, A.d-21).
Response: Use of personnel-dosimeter data as a basis for imposing
penalties or for taking legal actions, involve issues which are outside
the scope of Federal radiation protection guidance. Such matters are
determined by regulatory authorities.
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2.10.16 The gross inaccuracy of personal monitoring devices leads to
underestimating doses and a false sense of security for workers (A.c-8).
Response: 'Proper'use and processing of'personnel dosimeters can provide
acceptably accurate exposure data. We do not agree, in general, that data
'from such dosimeters are "grossly inaccurate-.." See also the responses to
comments' 2.3.9 and. 2.10.il. ' ' " . ' ' . '.
2.10.17 Occupations involving unsealed sources, dust problems, or high
yield source material will require complex monitoring systems to comply
with the proposed guidance (E.a-3).
Response: Monitoring systems to comply with these recommendations need,
in general, be no more complex than has been required heretofore.
Increased complexity might occur for some operations where changes in
metabolic models lead to greatly reduced derived limits and the margin of
safety is correspondingly reduced. However, this would have occurred
whether or. not Federal radiation protection guidance was revised (EPA84b).
2.10.18 . The proposed guidance will reduce the effectiveness of lapel air
samplers" as-.a ..tool: for., providing timely exposure evaluations (Bia-16).
"..''
Response: -On the contrary, such samplers could 'provide the means for
readily evaluating' the significance of suspected radionuclide intakes.
2.10.19 A guide on an acceptable means of measuring whole body dose is
needed (A.a-41).
Response: Note 3 of the recommendations provides references.for such
means.
2.10.20 There are so many difficulties in monitoring a total body
exposure that attempting to regulate a partial body exposure
is unreasonable (A.a-38, A.b-10).
Response: Such difficulties do not preclude the need to control
partial-body exposure. Usually this can be accomplished by the simple
conservative measure of monitoring the most exposed part of the body and
treating this exposure, for control purposes, as whole body exposure.
2.10.21 Improved dosimetry will be needed to monitor doses at the lower
limits on feet, ankles, and forearms (E.a-5).
Response: We disagree. The limit for the extremities is 50 rems. This
is 10 times the limiting dose equivalent for whole-body exposures.
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2.10.22 Indirect measurements, such as air concentration or exposure'
duration and/or body burden measurements, should be considered to be
acceptable methods for the demonstration of compliance with the proposed
guidance .(B.a-33,' B.a-46,B.b-2, E.a-2, E.a-2). .
Response: We. agree,'.-in general; although at higher doses approaching the
Xtimlts indirect -measurements may not 'always be., sufficient.
, * * " * . .
':.'.' \ '...* . ' .' V ' . :. ..'''; '''.
'2.10.23 The limits that would be imposed by the EPA recommendations are
so restrictive for plutonium that the existing state-of-the-art does not
permit the detection of the proposed limits (E.b-7).
Response: The premise of the comment is incorrect. Plutonium is one of
the radionuclides for which the derived air concentration (DAC) is
significantly reduced due to revised metabolic models. This change is not
imposed by;the recommendations; rather, it is the result of improved
knowledge of how much dose is delivered by a given intake of plutonium.
Regarding.existing state-of-the-art, detection capability for exposure at
derived limits (DACs) is adequate, but the adequacy of detection of intake
(ALls) corresponding to committed dose depends on timing of urine and/or
fecal sampling.(See the response to comment 2.10.14). See also the
responses' to-comments 2.10.1 and 2.10.4.'
2.11 ENGINEERING CONTROLS/DESIGN LIMITS
2.11.1 EPA's proposed guidance totally ignores engineering controls
which are the preferred method of reducing exposure (A.c-6, D-ll).
Response: We do consider engineering controls to be important. However,
Federal guidance specifies.what is required, while the regulatory agencies
and management determine how those requirements are to be met.
2.11.2 Exposure levels should be based on technical feasibility (A.c-7).
Response: We agree, to the extent that technically feasible levels are
ALARA. However, we do not agree that exposure should be reduced to the
lowest - levels that are technically feasible, without regard to costs and
other relevant factors. The recommendations require exposure to be kept
ALARA by taking all relevant factors (including technical feasibility)
into consideration, on a case by case basis. This will assure the most
efficient use of resources to provide radiation protection.
2.11.3 The low average doses received by workers are the result of
extremely conservative engineering design (A.d-38).
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Response: No response required.
2..11.4 . Rather than set-exposure limits for workers, EPA should replace
the.ALARA principle with a design limit for facilities" of 500 mrem/yr.
This design .limit should not -be construed as a regulatory limit (A.a-38),
Response: Design -limits for facilities are not within the scope of
federal, radiation protection-', guidance. Such limits,, however, could be
specified by regulatory agencies, on either a generic or case-by-case
basis. However, imposition of a single design limit, e.g., 500 mrem/yr,
to be applied to all facilities without regard to site-specific" factors,
could lead, in some cases,, to serious misallocations of resources and to
unwarranted costs, and, in others, to unnecessarily high exposures.
2.12 QUALITY AND OTHER MODIFYING FACTORS
2.12.1 EPA should specify quality factors so that all the various
effects, of ionizing radiation can be added to determine the magnitude of
the total injury (C-8). -'...,.
Response: Footnote 3 of. the recommendations provides, in part, that:
"The values specified by the International Commission on
Radiological Protection for quality .factors and dosimetric
conventions for the various types of radiation...may be used..."
We will recommend other factors when and if they are more appropriate.
2.12.2 Quality and other modifying factors should be dealt with by the
regulatory agencies (A.d-13).
Response: See the response to comment 2.12.1.
2.12.3 Reevaluation of the Nagasaki and Hiroshima data suggests a quality
factor of about 10 for fission neutrons at dose rates below 25 rads, not
the quality factor of 50-100 suggested by BEIR-III (A.b-1).'
Response: There appears to be an error in interpretation of BEIR-III.
Neutron RBEs are 27.8 in the LQ-L model and 11.3 in the L-L model in
BEIR-III [Table V-8, p. 184]. The RBE of 27.8 was used in the "preferred
model" in BEIR-III, the LQ-L model [equation V-10, p. 187].
As regards what will happen when the reevaluation of Hiroshima and
Nagasaki data is complete, it is premature to make an estimate. Both
gamma and neutron air kerma estimates and the proper shielding factors for
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individuals are still in a state of flux. It may be possible to
reestimate RBEs when the dose reassessment in Japan is complete, hopefully
late in 1986.
2/.12.4--.How can limits, be. set. in terms .of-dose equivalent, without an
.'agreement .upon unifprm.'parameters that should be used' in the determination
of quality (A.d-22). ,'.'. ' .' ' ' . '
, * .. ' * ' ' . - ' ' -
-..* * ---.: . ,,. . - . -'..- . . ,
Response: Use of quality factors, dosiraetric conventions, and metabolic
models are specified in Note 3. See also the response to comment 2.12.1.
2.12.5 It is undesirable to leave the specification of quality factors
and metabolic models to the discretion of the user or regulatory agency,
as suggested by EPA in Note 3 (B.a-8, B.a-34, E.a-4).
Response: The intent of the recommendations is that ICRP quality factors
and models be- used, to the extent feasible. The use of the phrase "may be
used," provides for unforeseen developments or situations that make it
desirable to use alternative quality factors and' models.
2.13 DIFFERENT GUIDES FOR .DIFFERENT CATEGORIES OF WORKERS
2.13.1 All workers should be' equally protected by law.' It is
unreasonable to support one set of limits and one level of risk for some
workers and a different set of limits and levels of risks for other
workers (A.a-5, A.c-6, A.c-7, A.c-8, A.d-13, A.d-22, B.a-34, B.a-37,
B.c-23, C-5, C-8)
Response: The recommended guidance specifies only one set of limits for
adult workers. However, competent authorities may, on the basis of ALARA
considerations, specify varying, lower limits for specific categories of
workers or work situations. We do not believe this represents unequal
protection under law, since the ALARA provision applies equally to all.
(The dose ranges identifying the proposed Ranges A, B, and C were not
limits. Those ranges simply served as a structure for specifying proposed
minimum radiation protection requirements. No such range system appears
in the final recommendations.)
2.13.2 The provision for certain categories or levels of exposure limit
based on type of work is a good idea (A.d-8, A.d-18, A.d-30, D-l).
Response: We concur. Recommendation 9 provides for such situations.
2.13.3 The practice of informed consent is the only practical solution to
the women worker exposure question, as labor agreements make no mention of
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distributing overtime on the .basis of sex or exposure .to ionizing
radiation (C-2).
Response: 'We- disagree. Informed .consent amounts to offering a pregnant
woman- the choice of subjecting her fetus to up to 5 rems, finding other
employment,-.or. not working while pregnant.. .
2.13.4 \ .Potential- legal conflicts should/be resolved prior, to implementing
any changes which'would discriminate between men and women (B.a-13).
Response: We believe the final recommendations are clear on the question
of. discrimination. The recommendation for protection of the unborn
specifies that conformance to the limiting value should be achieved
"...without economic penalty or loss of job opportunity and security...."
See also the response to comment 3.8.22.
2.13.5 The rationale for establishing different guides for different
categories of workers is not clear (A.d-22).
Response:- See the response to comment 2.13.1.
2.13.6'- Lower exposure levels should be used for women, as they are the
most sensitive' segment of the-population (A.a-38).
Response: - The risk differences between men and women are believed to be
relatively small, and in any case are not known with sufficient confidence
to justify establishing two different sets of limits. See the responses
to. comments 1.4.1, 1.4.2, 1.4.9, 1.4.21, 1.4.22 and 1.4.26.
2.13.7 Current radiation protection guides are adequate for medical'
radiation workers, although current facility design requirements do not
measurably affect occupational exposure (A.b-10).
Response: None required.
2.13.8 Guides should be developed for temporary workers (A.a-5).
Response: The recommendations apply to all workers, regardless of their
status as regular, transient, or temporary. We are aware that there are
problems associated with temporary workers, such as recordkeeping and the
use of such workers for short periods near the dose limits. Provisions
(e.g. regulations and regulatory guides) to assure compliance with the
recommendations are the responsibility of the regulatory agencies. EPA
will monitor the implementation of these recommendations, and, if
warranted, propose supplementary recommendations or issue clarifications
of this guidance. See also the responses to comments 2.3.2 and 2.3.7.
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2.13.9 Guides should be based on health risk, 'not the type of..wo-rk
(A.c-6, A.d-13, A.d-22, B.a-34, B.c-23). ". ' _.
Response: We- agree, and this is reflected in the recommendations for
limiting values. However,,. .the type of work does affect the dose levels
that are ALARA, .:as. in the past. ,_ . . .-. ...... -..
2. 13,. 10. Dif.ferent. -guides^ for different classes of workers must* not be used
as a disguise for discrimination.'' Exposure limits should be set at ; a
level that protects the most vulnerable worker (A.a-38, A.c-7,.B.a-13,
C-5, C-6, C-8).
Response: See the responses to comments 2.13.1 and 2.13.4. The
recommended limits provide for the protection of such broad classes -as
adult workers, minors, and the unborn. We know of no means for_
predetermining which individual adult workers are "most vulnerable," nor
the' applicable risk factors. See also the response to comment -2.1-12 i
2 i 13. 11 Exposure' limits for the- general public should apply to nonnuclear
workers exposed to radiation in the workplace (A.d-22).
i Response:'.'- See the- '.response tb- comment 2". 13. 9. The comment er does not
provide.' 'i'' oasis for such, differential treatment. However, the guidance
provides for establishing lower limits for groups or classes of workers
when this, is justified on the basis of ALARA. See the responses- to
comments 3.6.1, 3.6.6 and 3.6.14. . .
2.14 OTHER ISSUES/CONTROVERSY
2.14.1 EPA should take a position on how to monitor the radiation
exposure of persons, wearing lead aprons during fluoroscopy. Dose to the
"whole body" is best assessed by a dosimeter bene.ath the lead apron, while
dose to the "lens of the eye" is best assessed by a dosimeter outside of
the lead apron at collar (neck) level. Which measurement should be used
to determine "lifetime dose"? (A.b-5).
*I»
Response: Actual "how-to" provisions are not within the scope of Federal
guidance, but are the responsibility of the regulatory Federal agencies
(and Agreement States). However, in this case, both measurements may be
needed, since there are limits applicable both to whole-body (effective),
dose and the lens of the eye. The final recommendations substitute
recordkeeping of cumulative dose and the admonition to avoid continued
exposure at or near the limiting values for substantial portions of a
working lifetime in place of the proposed admonition to maintain lifetime
dose below 100 rems.
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2.14.2 To reduce overexposure to radiation from medical and dental x-ray
equipment, the operator of the radiographic equipment should be competent
in radiation safety and technique (A.d-30). . '
Response: Recommendation 7 provides for this.
2.14.3' There should be 'two main types of numerical exposure limits:
first., a-- s.trict design limit £or purposes of guiding personnel in
designing facilities and procedures, and second, a worker protection limit
expressed in terms of long-term exposure limits with an upper limit over
short periods of time (A.a-38).
Response: Design limits for new facilities and procedures are not within
the scope of Federal guidance. See the response to comment 2.11.4. With
respect to limits for longer and shorter periods of time, since there is -
no biological basis for imposing restrictions for different periods, these
recommendations do not do so. This, however, does not obviate the
imposition of limits for shorter term periods, for management purposes, by
regulatory agencies or by management at the user level, or by both.
2.14.4- EPA guidance p.n internal exposure should address accidental
internal' '.exposure,, as internal exposure- is seldom planned or deliberate
(S.a-5). ' '. ": ' ' /..'. ' .
Response: We agree. Recommendation 4 provides guidance for such.
situations. ' *
2.14.5 Society must decide whether or not society's gene pool should be
damaged, not the individual radiation worker (A.c-6).
Response: The potential risk to society's gene pool from occupational
radiation exposure is limited by the limiting values for dose for
.individual workers. This recommendation, when approved, would represent a
societal decision that includes consideration of the risk of genetic
effects.
2.14.6 EPA should maintain one year as the averaging period over which
dose rates apply (B.a-34).
Response: Except for protection of the unborn, limiting values for dose
and dose commitment in the recommendations are for one year. See the
response to comment 2.14.3 for further discussion.
2.14.7 There is a problem in communication and public education when the
ideals of the BEIR committee, recognized for purposes of scientific
conservatism, are written as regulations (A.d-36).
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Response: The findings of the BEIR committee were intended for use in
establishing guidance and regulations. That was the basis of the charge
to. the BEIR committee by EPA. . . '
2.14.8 The proposed guidance is based partially on the philosophy that
all.the,workers,are already down in the proposed exposure ranges.
However-, that philosophy c'ould repeat itself in the future, resulting in
changing regulations without a.,cutoff .(A..d-38).
Response: The comment is, in part, true. However, the burden involved in
maintaining a given level of protection is also considered before lowering
limits.
2.14.9 Radiation exposure guides should not be provided for periods
shorter than one year (A.d-22).
Response:. Guides for periods shorter than one year are not included in
either'proposed or final recommendations, with the exception of those for
protection of the unborn. However, also- see the response to comment
'2.14..3. ..........
2.14.10 Ehy-sical exams and medical tests for workers in high risk jobs
should be paid for b'y the employer and the frequency of such exams should
be set forth in the guidelines (A.d-8).
Response: These are regulatory matter's not within the scope of Federal
radiation protection guidance.
2.14.11 Employee protection and monitoring should be a requirement for
all licensing of equipment and reimbursement for treatment and diagnostic
procedures which involve radiation exposure in hospitals, clinics, and
private practices (A.d-8).
Response: These are regulatory matters outside the scope of Federal
radiation protection guidance.
2.14.12 Employees transferred out of high radiation areas after having
received limiting radiation doses should retain full job security,
seniority, and pay (C-5).
Response: We agree. The guidance specifically covers this situation with
respect to exposure of pregnant women. See the. response to comment
2.13.4. However, the handling of such cases is the responsibility of the
employer and the Federal agency having regulatory or administrative
jurisdiction.
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2.14.13 The' proposed guidance would require approximately 20,000
additional special procedures and radiation therapy technologists (A.d-14)
Response: This 'could be- possible only under unreasonable interpretation
of the requirements of .the minimum radiation protection requirements of
proposed .recommendation. 4. ,The final recommendations do not contain this
provision.'" '' ' ' "" ''' '"'' ' ' ---.
2.14.14 The proposed guidance, by limiting the availability of trained
workers,' would have a negative impact on safety (B.a-38).
Response: We disagree. It is the responsibility of users of radiation to
ensure that sufficiently trained workers are used to assure physical
safety as well as ALARA exposure. See also the responses to comments
1.9.5, 1.9.16 and 2.3.5.
2.14..15 To. assure objectivity .the DOE -should be relieved of its
responsibility for radiation health-effects research (A.c-6).
Response: .This question is outside the scope of Federal radiation
_pr.pt.ec.t'ion: guidance.,for, occupational.; exposure. ..
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SECTION 3.0 PROPOSED RECOMMENDATIONS
3.1 - JUSTIFICATION '
3.1.1 .. Implementation of justification oh a detailed individual work
situation. basis 'will- 'result in severe administrative costs (A.a-12, A.d-9,
A.d-29, A.d-42, B.a-5, B.a-8, B.a-12, B.a-14, B.a-28, B.a-32, B.a-48,
B.a-53, B.c-22, E.a-5, E.b-3).
Response: This comment was sometimes made in reaction to proposed
Recommendation 1 and sometimes in reaction to proposed Recommendation 4.
Recommendation 1 in existing Federal radiation protection guidance
(25 F.R. 4402; May 18, 1960) states:
"There should not be any man-made radiation exposure with-
. out the: expectation of benefit resulting from such exposure.
Activities- resulting in man-made radiation exposure should be
authorized for useful applications provided [the] recommen-
dations set forth' herein are followed.'"
We are not aware of any -adverse impact in terms of "severe administrative
costs" in the over 25 years of experience with this requirement.
.Cpmmenters did not present data supporting any- such impact, but,* .
instead anticipated future impact. Proposed Recommendation 1 was intended
to continue the same requirement as that in existing Recommendation 1.
Since it was commonly misinterpreted, it has been reworded in the final
recommendation as follows :
"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."
We do not foresee any unwarranted costs arising from this recommendation.
Also, see the response to comment 3.1.2. Regarding the implications of
Recommendation 4, see the responses to comments in Section 3.4.
3.1.2 Justifying all exposures on a cost/benefit basis is unnecessary,
considering nonexposure alternatives (A.a-39, A.b-23, A.d-18, A.d-29,
A.d-40, B.a-8, D-2, E.a-3).
Response: Recommendation 1 concerns assuring an overall benefit from an
operation or practice that involves radiation exposure of workers. Such a
determination necessarily includes considering alternatives (if any) that
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do not require radiation exposure. Determining whether a specific
instance of worker exposure to radiation from an already justified
operation or practice is necessary or not, may or may no't involve a
judgment about whether the exposure is justified, depending upon the
specific circumstances. This is a matter for management of programs for
radiation protection to decide. Maintaining justified worker exposure
ALARA and;:within the,, limiting, dose for individual workers are. governed by
recommendations 2-10. ' . .
3.1.3 Exposures from routine operations and maintenance are considered
at the time a. plant is designed. ALARA provides guidelines for any other
exposures. This is sufficient; additional justification is unnecessary
(A.d-42, B.a-8, B.a-10, B.a-12, B.a-14, B.a-27, B.a-36, E.a-2, E.b-1).
Response: Although this may often be true, it is not always the case.
New practices may be considered for institution at an existing plant, and
it may be appropriate to consider their justification under recommendation
1 before instituting them. See also the response to comment 3.1.2.
3; L.4 Justification of occupational .exposures on the basis of net
benefit -cannot .be. done until, a- dollar /person-rem figure is established
(Ai;a:-40^.A.drl.3V"B\c-10) :--';- ;' .' >. : ' T; '"
Response: The term "net benefit" does not require chat 'precise
quantification be carried out. In any case, the term "net" does not
appear in the final recommendation. . - ' ,
3.1.5 As written, Recommendation 1 is not adequately directed to
limiting occupational exposure. Better guidance, primarily on assessing
net benefit, is needed by both implementing agencies and practicing health
physicists (A.d-23).
Response: Recommendation 1 is aimed at preventing "unnecessary" worker
exposure to radiation. Limiting doses from "necessary" exposures and
keeping "necessary" exposures ALARA are covered in separate recommenda-
tions. See the response to comment 3.1.4.
3.1.6 The efforts required by Recommendation 1 would divert key
technical and management efforts from protection activities (A.d-18,
A.d-42, B.a-5, B.a-28).
Response: See the responses to comments 3.1.1 and 3.1.2.
3.1.7 Justification of exposures must be on a generic basis (A.d-42,
B.a-2, B.a-5, B.a-8, B.a-9, B.a-11, B.a-32, B.a-33, B.a-48, B.a-53).
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Response: We- agree that this will often be the case. However, it may
also be appropriate for individual practices or operations.
3.1.8. Recommendation 1 is impossible.to implement (A.a-10, A.b-6, A.d-11,
B..C.-23, _£'.^-3,.. E:.a-5, E;.b-3).. ,- . .. ,'...;. .. .. V :
Response: ..This is clearly, not'the case, since it has been implemented for
25 years. See the responses'to comments 3.1.1 and- 3^1.2.
3.1.9. Justification could be very beneficial, if carried out
conscientiously (A.a-38, A.d-6, B.a-29, E.a-6).
Response: We agree.
3.1.10 To whom is the justification to be addressed? (A.a-7, A.b-23,
B.c-20, B.c-21, B.c-22, B.c-23, E-.a-2, E.a-5)
Response: Justification is reviewed through a variety of means. One
example is the preparation of. Environmental Impact Statements. Another
example, is'-.the-.,agreements, reached .in. collective bargaining. Regulatory
agencies' may make such judgments. In other cases there may be no
immediate review. However, such determinations are open to challenge and
revised by society on a continuing basis through the various processes of
government and other institutions.
3.1.11 What are the criteria for justification'? (A.a-10, A.a-40, A.b-23,
A.d-11, A.d-23, A.d-29,, B.a-5, B.a-7, B.c-20, B.c-22, E.a-5, E.b-4)
Response: Criteria for justification are that the benefits of an activity
are judged to exceed its costs, and that this overall benefit is greater
than that achievable through alternative means not requiring radiation
exposure.
3.1.12 Will justification be required for each occupational category of
exposure, or for every individual exposure? (A.b-23, B.a-5, B.a-7, B.c-20,
B.c-22).
Response: See the responses to comments 3.1.1, 3.1.2, and 3.1.3..
3.1.13 EPA should delete Recommendation 1 and adopt the ALARA statement
in ICRP-26 (B.a-7, B.c-20, B.c-22).
Response: Recommendation 1 is not a substitute for ALARA. Recommendation
1 corresponds to the first of the three main features of the ICRP-26
system of dose limitation: "no practice shall be adopted unless its
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introduction produces "a positive net benefit." The recommendations also
include ALARA provisions that are effectively the same as those in
ICRP-26.
3.1-..14.'. The need to consider alternatives not involving exposure to
^ad-iatioTi could .'lead .to regulatory interference and abuses,.' particularly
inr.deteraining appropriate medical procedures (A.b-5).
Response: Regulatory "interference and abuses" should be identified and
eliminated on specific merit; the mere possibility of abuse should not
prevent making a recommendation to avoid nonbeneficial practices.
3.1.15 Exposure limits should reflect acceptable levels of risk that are
comparable to other safe industries. Industry should then be free to
operate within those limits without the added burden of justifying each
exposure (A.a-38, A.d-13, B.a-26, B.b-3, B.c-12).
Response: See responses to comments 3.1.1 and 3.1.2. We note that
operation simply within exposure, limits alone is, in any case, not
sufficient.' Two other-features are inherent elements of an adequate
system of. dosey limitation,, namely, (IX-elimination of "unnecessary"
-.exposure^: an(f (2)' maintaining; "necessary"'exposures ALARA. Implementation
of these two features- is a continuing function of the operational
radiation protection organization of each activity. See also the-
responses to comments 1,6.11, 2.1.11 and 2.7.11.
3.1.16 The justification for allowing any exposure is the trading of
human life for profit. An individual can only make such a choice if he is
completely informed of the dangers. And a society can only permit such a
choice if it is willing to pay for the cancers and genetically damaged
children that result (A.a-5).
Response: The first premise might more accurately have replaced the word
"profit" by "beneficial human activity." Since all jobs (radiation or
nonradiation) entail risks, this same premise applies to all jobs.
Recommendation 7 addresses education of workers on risks from radiation.
Societal responsibilities for health care are not addressed by this
guidance.
3.1.17 EPA has confused the concepts of justification and optimization.
The atomic energy act justifies the peaceful uses of nuclear energy and
ALARA optimizes exposures (3.a-24, E.b-1).
Response: The Atomic Energy Act does not "justify" any and all peaceful
uses. Its purpose is to further the development of justified peaceful
uses, and judgments on justification must be made independently.
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3.1.18 Justification of exposures should not be adopted as a regulatory
obligation (A.a-13, A.a-39, A.d-9, A.d-14, A.d-18, A.d-40, E.a-2, E.b-1,
E.b-3). - .
Response:. See the responses to comments 3.1.1, 3.1.2 and 3.1.17.
3*1.. 19 The extent and nature of justification should be left to the
regulatory agencies-implementing the guidance (A-d-13, B.a-33., E.a-2).
Response: In general, this is true. However, see also the response to
comment 3.1.11.
3.1.20 The word "justified" in Recommendation 1 should be changed to
"justifiable" (A.d-29).
Response: The word "justified" does not appear in final guidance. See
the response to comment 3.1.1.
3.1.21 EPA is "waving the flag of carcinpgenesis" instead of presenting
s'cie^ific:;_'iustif±ca'tion.;for/the._gul.delines. (B.a-26).
Response: 'We believe that our review of published studies on radiation
risk (see for example the response to comments 1.4.1, 1.4.2, and 1.4.3.)
and effects of exposure of .the unborn.(see for example response to
comments 3.8.15, 3.8.17, 3.8.52, and 3.8*.57) accurately reflects'the
substantial scientific basis for estimation of carcinogenic risks from
exposure to radiation.
3.2 AS LOW AS REASONABLY ACHIEVABLE (ALARA)
3.2.1 The intent of Recommendation 2 is good (A.a-10, A.a-39, A.a-49,
A.a-50, A.a-51, A.b-18, A.b-26, A.d-6, A.d-11, B.a-5, B.a-8,' B.a-9,
B.a-24-, B.a-33, B.a-46, B.a-48, B.a-53, B.c-20, D-2, D-5, E.a-2, E.a-6,
E.b-3). .
Response: No response required.
3.2.2 Existing ALARA programs have been very effective (A.a-19, A.b-26,
B.a-3, B.a-6, B.a-9, B.a-11, B.a-14, B.a-26, B.a-27, B.a-28, B.a-32,
B.a-33, B.a-34, B.a-36,.B.a-38, B.a-44, B.a-48, B.a-50, B.a-53, B.c-21,
B.c-22, E.a-5, E.b-8).
Response: We agree-
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3.2.3. EPA's .recommendation is unnecessary given existing ALARA programs
and regulations (A.a-19, A.a-4l, A.d-18, B.a-26, B.a-27, B.a-28, B.a-33,
;B.a-34, B.a-36, B.a-44, B.c-23).
Response: We disagree. The ALARA provision in Federal guidance provides
a.basis for existing ALARA programs. Such provision should continue to
.'provide, the--basis.--.for. future such.programs. . . ' ;;'
3.2.4 ALARA should be applied only as an operating philosophy and not a
standard until it is defined in quantitative terms such as dollars/person-
rem (B.c-10, B.c-21).
Response: The recommendations in Federal guidance are not regulatory
standards. They constitute guidance for the Federal agencies in the
conduct of their radiation protection activities. While a fixed, dollar
value per person-rem may facilitate, some ALARA analyses, it is not
necessary for such a value to be established under Federal guidance.
Different values may be appropriate for different situations, and for
different periods of time. Many ALARA determinations can be made without
such a value. We have concluded that it is not possible or even desirable
to recommend a value for a person-rem in Federal guidance at this time.
See the -response; .to comment 3.1.4. -.
3.2.5 EPA'shoul'd define a de minimis'dose so that jobs resulting in
exposure below such a dose would be excluded from ALARA considerations
(A.b-7, B.a-14). ' There must be some limits-below which further reductions
are unjustified (B.a-1).
Response: We recognize that for workers engaged in certain types of
activities, maximum feasible exposures may be so small as to warrant their
not needing or requiring regulatory controls. This concern was expressed
under "other considerations" in the preamble to our proposed guidance by
the following statement:
"Regulatory agencies will have to use care in selecting
classes of workers whose exposure does not need to be
regulated. In selecting such classes we recommend that
the agency.consider both the collective dose which is
likely to be avoided through regulation and the maximum
individual doses possible."
As- this statement reflects, application of the ALARA principle in an
activity of a given type requires optimizing both collective and
individual doses. Since this is generally a complex function involving
many factors, which can vary from one activity to another, the optimal
solution, in terms of individual doses, is not necessarily the same for
all situations. We conclude that a single de minimis dose that applies to
an individual for all situations is neither feasible nor appropriate.
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3.2.6 ALARA must be implemented on the basis of expert judgments. To try
to regulate the implementation of ALARA could be counter-productive
(A.d-40, A.b-10,. B-a-38, B.a-46, D-10). . . .
.Response:. We agree 'that .judgments are required in applying the ALARA
.principle,; but--.'this-)does, not; eliminate .the .need for. Federal guidance and
corresponding regulations to require that this principle be implemented.
.We agree,.'. however, that, regulations "on ALARA should be formulated with
care to avoid causing possible counterproductive consequences.
3.2.7 Implementation of ALARA should be left to the regulatory agencies
(A.a-21, B.a-24). .
Response: It is.
3.2.8. Regulators, not industry, should bear the burden of proof that
exposures' below 5. rem/yr are- not ALARA (B.c-12).
Response: It-is the responsibility of 'regulators to assure that industry
applies. ALARA. "Burden of .proof" responsibility, therefore, exists at two
.levels-': ."first.,1; 'industry'should-ber able to demonstrate to regulators that
ALARA is. being applied, and %second, regulators should be able to
demonstrate that they are requiring industry to do so.
3.2.9 ALARA should be applied to individual rather than collective dose
so that individuals are not sacrificed to save the group (C-4).
Response: -Reducing the dose to one individual at the expense of
increasing collective dose of the group by a significantly larger amount
would amount, on the other hand, to sacrificing the group to benefit the
individual. It is true that repetitive assignments to one individual to
perform a given task involving high level exposure simply because he
becomes expert (and presumably receives a smaller dose per task than would
other workers) is also not in keeping with the ALARA principle for
individual dose. Equity considerations would suggest a rotation of
assignments, even if the collective dose should increase somewhat at the
start. Thus, a difficult balance is involved in the trade-offs between
equity and reducing collective risk. Care must be exercised in assuring
that equity considerations are not disregarded in efforts to keep the
collective dose ALARA. Hpwever, keeping the collective dose ALARA is most
generally achieved by methods (e.g., engineered safeguards) which also
reduce the exposure of each worker in the group or task involved, so that
such difficult decisions do not occur in the majority of occupational
exposure situations.
3.2.10 Current practice of maintaining each task ALARA insures that
collective doses are ALARA (B.a-14, B.a-26, B.a-32, B.a-38, B.a-48).
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Response: No response required.
3.2.11 EPAJs recommendation to. hire additional workers to keep'within the
proposed limits is not compatible with ALARA (A.a-3, B.a-44, E.b-7).
Response:- "We disagree'. .See title response tp-comment 3.2.,9.-
3.2.12 Incorporating the ALARA concept in the guidelines may result in
legal liabilities, as it could be interpreted as overriding the guides
provided in Recommendation 3 (A.d-29).
Response: These are independent requirements that must both be satisfied.
3.2.13 EPA should adopt the ALARA language of the ICRP, which includes
the need to consider social and economic factors (B.c-20, B.c-22, E.a-4).
Response: We agree and equivalent wording appears in the final
recommendations.. . . . ' . ... .
- . ........ .*... --... . . .- ..... .
3. 2*. 14' - Since rigorous,' "quantitative implementation procedures for ALARA
have not been perfected, EPA should add a note that ALARA implementation.
should proceed on a structured qualitative -basis (E.a-6).
Response: We agree. The preamble to the recommendations makes it clear
that ALARA will require qualitative judgments.
3-2.15 EPA should emphasize that ALARA is the fundamental concept of
radiation protection (A.b-10, A.d-23, B.a-19).
Response: We agree that ALARA is of fundamental importance. ALARA is one
of the three principles that constitute the basic system.of dose
limitation in Federal radiation protection guidance for occupational
exposure: (1) elimination of unnecessary exposures; (2) keeping necessary
exposures ALARA; and (3) not exceeding the dose limits.
3.2.16 EPA should emphasize that meeting the RPG limits is not ALARA
(A.a-38, A.c-1, A.d-23).
Response: We agree, and this point is made in the final guidance.
3.2.17 The phrase "sustained effort..." in Recommendation 1 should be
clarified so that it does not imply more than continuing professional
evaluation (E.b-2).
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Response: The recommendations require more than "continuing professional
evaluation." For example, workers should play a major role in keeping
their exposures ALARA.
.3..2.IS EPA-should adopt- the. following wording for Recommendation 2: "for
'any -justifiable .activity :a sustained effort should'be made to assure that
the collective dose of all. individual's involved" in this activity is as low
a.s is . reasonably, achievable"' (A.b-5,. Ai.d-29). ' .
Response: We believe Recommendations 1 and 2 clearly include that intent.
3.2.19 The theory of radiation ho tmesis may invalidate the concept of
ALARA (A.d-35).
Response: To date, the theory has not received- sufficient scientific
support that it needs to be considered seriously. In any case, it is not
clear that it would apply at occupational levels of exposure. See the
response to comment 1.4.15.
3..2.20 r The:. ALARA" conc.e-pt. should .be .dropped since it has resulted in
'annuaiv.expo'sufe- limits being- Improperly'adopted as' engineering design
criteria. (A.a-38). .
Response: We-do not believe the premise is generally correct. Even
if it were,'the solution, would be to enforce use of the ALARA concept
in engineering design, not to drop it.
3'.2.21 Inclusion of proposed Recommendation 2 makes proposed
Recommendations 1 and 4 superfluous (A.a-12).
Response: We disagree. Recommendations 1, 2, and 4 deal with
justification, optimization, and implementation of optimization,
respectively. These are separate matters.
3.2.22 -Adoption of the proposed guidelines codifying ALARA will make
protection programs less flexible and effective (A.a-41, A.a-45, A.d-21,
A.d-31, B.a-27, B.a-32, B.a-34, B.a-38, B.a-48, B.c-20, B.c-22, E.b-8).
Response: This was not the intent of the proposed recommendation on
minimum radiation protection requirements, and we do not believe it would
have been their effect. In any case, the issue is moot, since proposed
Recommendation 4 does not appear in the final recommendations.
3.2.23 ALARA is too vague in a legal sense to serve as a basis for
regulation (A.a-38).
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Response: ALARA has been an explicit part of existing Federal, guidance
since 1960, and has been a successful and integral feature of the radiation
protection programs of Federal agencies. Insofar as implementation of the
ALARA principle results in regulatory requirements, such implementations
are not vague and have a legal and enforceable meaning. See-the response
to comment 3.2.12. . .
3.3' RADIATION PROTECTION GUIDES (RPGs)
3.3.1 WHOLE BODY, INCLUDING 5(N-18)
3.3.1.1 EPA has not presented a convincing .scientific argument that the
risk associated with a 5 rem annual limit is substantially lower than that
associated with a 3 rem quarterly limit coupled with the 5 (N-18)
cumulative limit (A.a-8, A.a-15, A.a-41, A.d-9, A.d-14, A.d-19, B.a-9,
B.a-18, B.a-20,' B.a-27, B.a-32', B.a-48, B.c-14, B.c-20).
Response: The proposed limi't permits a dose of 5 rems in a year to an
adult- worker,, regardless of the .worker.' s age. Existing guidance permits
in:-exces9r"6f:: 5-- 'rems..up' to- a 'limit' af ,12' rems in a year, if the
'accumulated dose does not exceed 5(N-18) rems, where N is the worker's age
in years. Thus, for example, under a 5 rem annual limit the maximum
accumulated dose for a specific worker first employed at age 40 for only 5
ye.ars would be a maximum of 25 rems (i.e., 5x5). Under a 3 rem quarterly
limit, the accumulated dose allowed would be 60 rems (i.e., 5x12).
It is true that the maximum lifetime risk possible under the new
recommendations is the same as under the former guides for a worker
receiving 5 rems every year from age 18 to age 65. However, the general
pattern of dose accumulation by individuals during an occupational
lifetime indicates that elimination of the 5(N-18) flexibility will reduce
cumulative dose and, hence, risk.
3.3.1.2 The imposition of the proposed 5 rem limit would increase the
work force by 75 percent (B.a-33).
Response: The comment is grossly in error. Independent studies indicate
that less than a few percent increase would be needed, at most, even in
those few industries that now deliver high doses to workers. We believe
even these studies are overly pessimistic, since only 0.1% of workers now
receive more than 5 rems per year (AIF80, CobSO, DOE80, Ku84).
3.3.1.3 A change in the limit to 5 rem/yr is not necessary in view of the
relative level of safety in the radiation industries and the inherent
margin of safety in radiation risk assessments (B.a-17).
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Response: This, view is not shared by EPA, the majority of commenters,
nor by national or international communities of radiation protection.
See the responses to comments 1.5.4 and 1.5.6.
.3.3.1.4. .The imposition of the.5 rem limit .would not substantially reduce
;_current exposures,, whilef it; would increase the administrative burden of
.radiation protection -(A. a-10, A.d-18).:
Response: The 5 rem limit should not impose-any increase in administrative
costs, since annual doses and cumulative doses are less difficult to record
than quarterly doses and the 5(N-18) record. See also the responses to
comments 3.3.1.1 and those regarding collective doses.
3.3.1.5 Because most exposures at nuclear power plants occur during the
six to seven week outages, the five rems per year limit, or some
straight-line interpolation thereof, would severely hamper activities
during-these outages (B.a-54).
.Response:' The contrary is true, since the recommended dose limit of 5 rems
for 'one year actually' provides more operational flexibility than a 3 rems
.per ..quarter ..Limit;. ; . -.-, : .; -. .' ......",.- .
3..3.1.6 A revision in the current 5(N-18). rems dose limitation to 5 rem/yr
would present problems -in performing major tasks at nuclear power plants
(B.a-50). ' . .
Response: We disagree. See the responses to comments 1.9.13 and 3.3.1.5.
3.3.1.7" An inflexible dose- limit of 5 rem/yr would require some work to
be deferred until the next calendar year (B.a-38).
Response: The comment implicitly assumes that use will be made of the
so-called 5(N-18) "budget." It is the intent of these recommendations to
prevent this practice.
3.3.1.8 The 5 rem limit might do more harm than good, because a larger
number of less skilled workers would have to be used to perform necessary
maintenance and modification work (B.a-47).
Response: See the responses to comments 3.3.1.5 and 3.3.1.6.
3.3.1.9 A change in the dose limits at this time will be misperceived by
the public and/or workers as indicating that radiation is more hazardous
than thought in the past (A.d-14, B.a-38).
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Response: If so, the public perception would be correct. The risk assumed
associated,, in 1960, with the previous limits was smaller than is now
estimated for the' same dose.
3%3:. 1.10 The S(N-18) cumulative dose limit should, be. retained; however,
the 3 rems. per'quarter restriction, .-which" is arbitrary, should be..
abandoned (A.a-4l). . .'. .
Response: We disagree. This proposal would allow very large annual doses
in some cases. For example, a newly-employed 26 year-old worker with no
previous accumulation of radiation dose could receive a dose of up to 60
rems the next five years. The opportunity for abuse of such a system is
obvious.
3.3.1.11 A quarterly limit of 3 rems should still be maintained, even if
an annual 5 rem limit is adopted (B.a-32, B.a-33, B.a-36, B.b-7, B.c-10).
Response: .Since there is no biological basis for specifying limits for
periods of less than'one year, except for the. unborn, we have not
specified such' shorter term limits. Regulatory agencies, may, however,
a.d'pgt;..l;imits- for. s-HortJe.r..pe.ri.ods..fqr; operational reasons. Such limits
should't?ke into account: the.need for operational flexibility required to
maintain doses ALARA. This might very well lead to a decision to retain a
3 -rem quarterly limit. See the' response to comment 3.3.1.5.
3.3.1.12 A quarterly limit should be retained to distribute the exposure
evenly (A.a-18, C-8).
Response: See .the response to comment 3.3.1.11.
3.3.1.13 The replacement of the quarterly limit with an annual limit
removes a radiation protection tool which assures management that the
worker's exposure is accurate within three months "(B.a-11).
Response: The absence of dose limits in Federal guidance for periods of
less than one year does not preclude regulatory agencies or management
from specifying administrative control levels or reference levels for
periods of less than one year.
3.3.1.14 If the regulatory agency were to impose a quarterly limit at
one-quarter of the 5 rem annual limit, or 1.25 rems per quarter, many
tasks at nuclear power plants could not be performed (B.a-48).
Response: There is no requirement that regulatory agencies do so. See
the response to comment 3.3.1.11.
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3.3.1.15 Any quarterly limit more restrictive than 3 rems would cause
unwarranted hardship and unnecessary costs (B.a-20, B.a-33).
.Response: See response to. comments 3.3.1.11 and 3.3.1.14.
3-v3-'.lu.l&;.. It .is not beneficial'-for the worker to. be exposed up to 5' rems
in a quarter, since he would be'unable to work for the remainder of the
.year (B.a"-33-). '.; . . -.
Response: This same comment applies to using up any limit (including the
previous value of 3 rems per quarter) early in the period to which the
limit applies. We assume that the same forces of self-interest on the
part of the worker (in the case of temporary employees) or the employer
(in the case of permanent or tenured employees) will operate under the new
limits 'as formerly.
3.3.1.17 The 5 rem annual limit is justified based on the recommendations
of the ICRP and'the NCRP (A.d-42, F-3).
Response: No response required. '
3.3.1.18 Setting annual-occupational exposure limits at a whole-body dose
equivalent of 5 rems is quite reasonable (A.b-9, B.a-53, D-2, E.a-2,
E.a-5, E.a-7).
Response: No response required.
3..3.1'. 19 The proposed 5' rem annual limit, coupled with a 100 rem lifetime
limit, will allow flexibility and at the same time restrict the maximum
dose (A.b-8, B.a-5).
Response: We agree. However, the "100 rem lifetime dose" was not pre-
sented in-proposed recommendations as a dose limit. The recommendations
now include an admonition to avoid exposures near the limit for a
substantial portion of a working lifetime, as a substitute for this
numerical objective. See also the response to comment 3.4.6.
3.3.1.20 EPA should establish quarterly limits equal to no more than
one-half of the proposed 5 rem annual limit (A.c-7).
Response: Dose limits for periods of less than one year, except for
protection of the unborn, are an operational matter left to the regulatory
agencies. See the response to comment 3.3.1.11.
3.3.1.21 Workers should have the option of building a "bank" for potential
exposures under the present 5(N-18) formula, with the worker assuming the
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responsibility of increased risk in return for higher compensation
(A.b-20).
Response: We believe that the existence of such a "bank," .which was
permit-ted under the old guidance, leads to the possibility of unacceptably
high ,lifetime risk.
'5.3,1.22- A workershould be permitted- to receive a 7 rem/yr external
whole body dose equivalent for routine plus planned special exposures and
an additional contingency of 3 rem/yr should be available (B.a-38).
Response: We disagree. The risk associated with 10 rem/yr is
unacceptably high.
3.3.1.23 The total of the exposure in excess of the 5 rem/yr should go
into a dose bank which should not exceed 25 rems over a lifetime (B.a-34,
B.a-38). . ....
.Response: There is no."dose bank" in final guidance. (See the response
to comment 3'.3.1.21.) However, -regulatory agencies may establish
provisions- for- unusual circumstances.-under .Recommendation 10.
3.3.1.24 The proposed' guidance, should', following the lead of ICRP-26,
allow.an exposure as high as 10 rems for a single .event (C-2).
Response: See the response to comment 3.3.1.23.
3.3.1.25' EPA claims that a 100 rem lifetime limit would be adequate to
insure that radiation workers would be as.safe as those in other
industries; if this is true, it would not be necessary to impose any
particular short-term or annual limits (B.a-38).
"Response: We made no such broad claim for the objective of a 100 rem
lifetime dose. See "also the response to comment 3.3.1.21.
3.3.1.26 Whole-body limits should be the following: for any radiation
worker - 5 rem/yr deep dose and 25 rem/yr shallow dose; for radiation
workers with recorded radiation histories - 15 rem/yr deep dose [limited
by 5(N-18) and 45 rem/yr shallow dose] (A.a-41).
Response: The recommendations provide a similar limit (50 rems) for skin
(which is approximately equivalent "shallow" dose)," based upon avoidance
of nonstochastic effects. A whole-body limit of 5 rem/yr deep dose
corresponds to the ICRP limit of 5 rem/yr effective dose equivalent. We
see no basis for allowing a higher dose to workers with recorded radiation
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histories. The substitution of a 5 rems per year limit for the 5(N-18)
rule obviates the need for making assumptions of previous exposure
history. See also the response to comment' 2.10.11.
3'.3.1'.27. ' Whole-body. limits- should be the following: 15 rem/yr deep dose
"and 45' rem/yr shallow 'dose.''" V . . : :
Response: 'See'the response -to-comment 3'.3.-1.26.-
3.3.2 GONADS
3.3.2.1 The separate limit for the gonads is the most "incoherent" part
of the Guidelines, since the total stochastic risk is the sum of the
somatic risk to all organs of the body plus the genetic risk (A.a-40).
Response: The cbmmenter assumes that the only "coherent" way to approach
risk.limitation is to combine all.effects designated as "stochastic" for
the purpose of limiting dose. This is 'an incorrect assumption. Genetic
; and. somatic--.effects : are; nor the'same.; The severity, and significance of
genetic'effects varies from inconsequential to lethal. Somatic effects
,are usually lethal. ' Furthermore, genetic effects occur only in
descendants of the individual receiving a dose, and somatic effects occur
only in the individual. It is necessary to make a judgment of the
relative severity-of and the importance of avoiding these quite different
types of effects in different groups of people (the workers who receive a
direct benefit from work involving exposure, and descendants who, in
general, may not, and who.clearly do not make the decision to assume the
risk). Only if this judgment is that the severity and importance of these
different risks (on a unit risk basis) are both the same is it appropriate
to combine them. In the proposed recommendation we did not elect to do
so. Limiting the genetic and somatic risks separately, as we proposed,
permits an independent judgment to be made (or changed) on genetic risk
without affecting the judgment on somatic risk. Final recommendations
combine these stochastic risks using the ICRP-26 weighting factors for
genetic vs somatic risk only because the difference in protection is
minimal, and it is in the interest of international uniformity.
3.3.2.2 The effect of placing the same nonstochastic limit (5 rem/yr) on
the gonads as on the whole body has effectively raised the weighting
factor for stochastic risk estimation for the gonads from 0.25 (ICRP) to
1.0 (EPA) (E.a-5).
Response: The comment is correct. In part, this compensates, for the
failure of the ICRP's weighting, factor to account for any genetic effects
beyond the 2nd generation. In practice, this limit would almost always be
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satisfied through the 5 rem limit for somatic stochastic effects, so that
the effective factor is 1.2, not 4. See the response to comment 3.3.2.1
for further discussion.
3.3-2.3 The.'proposed annual limit of 5 rems is sufficient to protect
against."genetic damage.'..rNo further action is. necessary (A.a-31, A.a-36,
A.a-46, B.a-5.2).' '.""''-'.' . ; '
Response: This comment is in agreement with our proposed guidance for
limiting genetic or mut.ational effects in progeny. It may be useful here
to distinguish between the two types of radiation effects in progeny.
Genetic (or "hereditary") effects refer to those affecting the progeny of
the irradiated person, and the risks of those effects is limited by
restricting the dose to the gonads of the irradiated person. Somatic
effects (teratogenic and carcinogenic) are manifested in children from
their exposure in utero. See Section 3..8 for further discussion of the
risks of such effects, particularly the responses to comments 3.8.15 and
3.8.51. '
3>3.3 :;.'.../LENS-; OF-EYE' .,. . ' '.:,,'.
3.3.3.1 We agree that a dose limit- to the eye lens should be maintained
at less than- 5 rem/yr (D-2). ' .
Response: The current consensus for protracted irradiation of the lens
with high or low-LET radiation is that a total dose equivalent of 1500
rems over an occupational lifetime would be below the threshold for the
'production of any lens 'opacificatioh that would interfere with vision
(ICRP 77). However, some opacities might be produced which, while not in
themselves detrimental to vision, might develop without further exposure
to the point of causing deterioration of vision. Therefore, the
recommended dose-equivalent limit to prevent- nonstochastic effects for the
lens of the eye over a working lifetime was reduced from 30 rems in-a year
to 15 rems in a year (ICRP80).
3.3.3.2 The lens of the eye has a threshold for vision-impairing opacity
at around 1000 rad (A.b-24).
Response: The dose value cited lies within the range of reported
thresholds for observed lens opacities that are not vision impairing
(ICRP80). See also the response to comment 3.3.3.1.
3.3.3.3 It takes exposures in excess of 200 rems to produce cataracts
(B.b-4, E.a-5, E.b-1).
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Response: See the response to comment 3.3.3.1.
3-. 3.3.-A The annual dose limit-to the lens of the eye should be increased
from .15 to 30 rems (A.b-14, B.b-1, E.b-1); to 50 rems (E.b-8).
Response:. Final' recommendations .specify an annual dose limit of 15 rems
for lens of eye in agreement with 'ICRP recommendations. See the response
to comment. 3.3.3.1..-. '.'. . '-...- ... ..-..
3.3.3.5 A limit of 5 rem/yr to the eye lens would bring a number of
radiation workers into Range C, which would require "professional
radiation protection supervision before and while such jobs are
undertaken"; which would impose considerable operational difficulties
(A.b-17, A.d-5).
Response: Final guidance adopts an annual limit of 15 rems for lens of
eye and the proposed ranges for the minimum Radiation Protection
Requirement do not appear.
3-3; ..3.-. 6.. .The 'p.ro.p.osed-, _RPGs-:: in- Recommendation 3a. of the guidelines are not
entirely understandable^. : For 'example, the dose-equivalent of 5 rems from
external sources cannot equal that of the lens alone (A.b-15, A.d-21).
Response: .We do not agree. The limit for lens of the eye is independent
of that for the whole body, as in the 1960 guides.
3.3.4 HANDS
3.3.4.1 EPA does not present adequate justification for reducing the
annual limit on hand dose from 75 to 50 rems (A.d-23, B.a-8, B.c-21,
E.a-2).
Response: Final recommendations adopt the ICRP-26 system of dose
limitation, in which nonstochastic effects are believed prevented by
applying a dose-equivalent limit of 50 rems in a .year to all tissues
except the lens of the eye, for which the limit is 15 rems in a year.
This ICRP limit is based on preventing any one organ or tissue from
receiving a total dose over a working lifetime that could lead to the
induction of nonstochastic effects. Although irradiation of extremities
does not include all skin of the body, there is no demonstrated need to
exceed 50 rems, even in glove box operations.
3.3.4.2 A dose limit of 50 rem/yr to the hands is reasonable (D-^2).
Response: No response required.
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3.3.4.3 Feet, forearms, and ankles- should be addressed in a category
labeled "extremities" with the same limit as the hands (A.a-41, A.d-23,
B.a-4, B.a-5, B.c-12, E.b-3, E.b-5).
Response: This has been done in the final recommendation.
3.3.4.4 -Feet should be included with'hands, whereas forearms and ankles
should be included -with'."'any other organ" (E-.b-8). "
Response: In the final recommendations, "hands" is replaced by
"extremities" (i.e., "hands and forearms, feet and ankles") for which the
annual limit is 50 rems. Forearms and ankles are therefore included in
extremities and are not included-in the "remainder" organs in the weighted
summation for the effective dose equivalent. This is done because it is
convenient to apply such a limit in practice, and there is no special
biological significance to the ankles and- forearms with respect to
radiosensitivity. Final guidance provides an expanded but not exhaustive
listing of tissues and organs to be considered in the ."remainder" and from
which five are selected for calculation of effective dose equivalent.
3;.3.,.4»5;.'Separate dose-.limits, f or the-forearms, feet,, and ankles equal to
those'proposed'by "the ICRP should be included in the proposed guidance
(A.d-9).'. '.'-.' ' . -; '
Response: See. the. response .to comment _3.3.4.4.
3.3.4.6 Since there is generally not a large dose differential between
the hands and forearms, the effective limiting factor under the EPA
guidelines would' be the'whole-body limit of 5 rem/yr (B.a-46).
Response: Final guidance limits the dose to hands and forearms
("extremity")- to 50 rem/yr. When the entire body is uniformly irradiated
then the hands and forearms are effectively protected to a 5 rem/yr limit.
3.3.4.7 EPA does not justify the reduction in the foot limit from 75 to
30 rems (B.c-21).
Response: The limit in final guidance for extremities is 50 rems. This
limit is also recommended by the ICRP. In addition, we know of no
requirement for extremity doses greater than 50 rems. See the response to
comment 3.3.4.1.
3.3.4.8 The whole-body limit may be controlling for the forearms and
ankles under the proposed EPA guidance, which could result in serious time
restrictions or major facility modifications (E.a-5, E.b-6).
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Response: Final guidance specifies extremities to. mean the forearms and
hands, or the lower legs and feet. The limit of 5 rem/yr would be limiting
for the extremities only in the case of essentially uniform irradiation of
the whole body. See the responses to comments -3-3.4.1 and 3..3.4.6.
3.3".4..9"" EPA.rs .justification-for'reducing the limit for; the forearm is
that "such.a high value is not needed"; this'is neither adequate
justification nor is-it necessarily true (A.a~-4, A.d-9, B.a-47, E.a-5,
E.b-7).
Response: Final guidance limits the extremity dose to 50 rem/yr rather
than the proposed 30 rem/yr. See the response to comment 3.3.4.1.
3.3.4.10 In applying the whole-body limit to the forearms, feet, and
ankles, EPA has not considered future activities such as decommissioning
and cleaning (B.a-47).
Response: The final recommendations provide a 50 rem/yr nonstochastic
limit of protection for. the extremities,: which are defined to include the
forearms and hands, or the lower legs and feet. The commenter does not
pxoyide; a..r.easoni why; such.future activities .would, justify a limit higher
.'than " th'e- assumed'':threshold"for nonstochastic effects.
3.3.4.11 The low proposed limit to the forearms could re-suit in high costs
for the chemical processing of plutonium, since remote operations'would
likely be required; this expense is not justified in light of EPA's
apparent reason for lowering the limit ("such a high value is not needed")
(E.a-5). .
Response: We do not believe that the modest reduction from 75 to 50 rems
would result in such major changes being required.
3.3.4.12 There are some occupational tasks in which the whole-body/skin
limits are notappropriate to the extremities; a case in point is work
inside a steam generator or a recently drained reactor cavity (B.a-28).
Response: The whole-body dose limit does not apply to the extremities or.
the skin. The applicable limit for both is 50 rems. See the response to
comment 3.3.4.1.
3.3.4.13 Extremity limits should be the following: For any radiation
worker - 50 rem/yr deep plus shallow dose; For radiation workers with
recorded radiation histories - 75 rem/yr (A.a-41).
Response: See the responses to comments 3.3.4.1 and 3.3.1.26.
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3.3.5 ANY OTHER ORGAN
3.3.5'.l EPA has not .adequately justified the selection of a 30 rem organ
limit, rather than the internationally-adopted value of 50 rems (A.a-40,
A.a-41, E.a-6). EPA should adopt the ICRP-26 organ limit of 50 rem/yr
B;a-32i;B;Q-lQ,-'E.a-5-, E,.a-6, E'.b-5VE.
Response: The final recommendations adopt the ICRP-26 annual limit of
50 rems.
3.3.5.2 EPA should adopt a value of 15 rem/yr as the organ limit, rather
than 30 rem/yr (A.c-1).
Response: This comment is apparently based on the precedent established
by the previous guidance, in which the organ limits addressed both
stochastic (e.g. cancer and genetic) risks and nonstochastic (e.g.
opacification of the cornea, skin erythema) risks. In the present
recommendations the so-called "organ" limit addresses only the latter type
of -risk. The former (stochastic risk) are addressed by the effective dose
equivalent limit of 5 rems through use of the organ and tissue weighting
fac.t.ora* .'.. .;.-..:.. ... . ... .-.-:. ....
3.3.5.3 A confusing precedent is set by EPA in including skin as a
specified organ within the weighted sum of annual dose equivalents, since
ICRP chose to exclude it (B.6-7)."
Response: The ICRP, at its 1978 meeting at Stockholm, noted that a
weighting factor equal to 0.01 (as proposed by EPA) was appropriate for
cases in which the detriment from skin irradiation was to be accounted for.
3.3.5.4 Is the dose equivalent limit to a small area of the skin the same
as .that to the skin of the whole body? (A.d-22, B.6-7)
Response: Yes. However, the dose is to be over an appropriate area of
the skin. As provided in note 3 of the proposed and final
recommendations, dosimetric conventions specified by the ICRP for
measurement of the various types of radiation may be used for determining
conformance to these recommendations. . Paragraphs 182 and 183 of ICRP
Publication 26 specify the appropriate areas for averaging as 1 cm^ for
external radiation and 100 cm^ for surface contamination of the skin.
3.3.5.5 EPA should define in the guidance what the organs are that are
protected .by the 30 rem organ limit (A.a-46).
Response: This has been clarified in the final recommendations.
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3.3.5.6 It is not clear what constitutes an organ; are the head and neck
governed by the whole-body limit of 5 rems or the organ limit of 30 rems
if lead glasses are worn to protect the eye lens? Does "whole-body"
literally.mean the whole body and not a "major part thereof," such as the
head and-trunk (A.b-24).
Response: This/ has -Been-,clarified in---the..final recommendations. The
.application of the' "whole body" limit is governed by'the degree of
exposure-of.individual organs, (e.g. the thyroid and such "other" organs as
thymus and brain).
3.3.5.7 Exposure to the four tissues which "have a sensitivity to cancer
incidence greater than for the whole body - thyroid, bone marrow, breast,
and bronchial epithelium - should be equivalent to whole-body exposure
(A.a-38).
Response: Even though some tissues have a sensitivity greater than that
of. average tissue, the total risk, from whole body irradiation cannot
exceed the sum of risks from all individual organs and tissues irradiated
at the same dose-level. The weighting' factors, represent.the proportion of
stochastic' risk'for each tissue when the whole body is irradiated
uniformly.. .' They, thus provide a consistent system for. calculating the
,'efi'ee'tive,;.dose.' equivalent, .regardless-".of' whether the whole body is
.irradiated-uniformly or.not.
3.3.5.8 EPA should consider addressing the problem of partial-organ doses
(A.a-14).
Response: In general, this is accomplished by averaging the dose to an
organ over the entire organ. See also the response to the comment 3.3.5.4,
3.3.6 WEIGHTING FACTORS
3.3.6.1 EPA has not sufficiently justified their departure from the
ICRP-recommended weighting factors (A.a-18, A.b-17, A.d-18, B.a-5, B.a-14,
B.a-34, C-5, E.a-5, E.a-6, E.b-5).
Response: The final recommendations adopt ICRP-26 weighting factors.
This was done because the difference in protection between use of ICRP and
the proposed EPA weighting factors is minimal and it is in the interest of
international uniformity. See also the response to comment 3,3.2.1.
3.3.6.2 There is no scientific validity in the weighted sum of annual
dose equivalents (A.d-19, B.a-9, E.a-5).
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Response: We disagree. There is now sufficient knowledge to permit the
summation of detriment according to the relative risks of irradiated
tissues. -
3.3.6.3 Devi-ation- from, the ICRP-26 values would cause much confusion in
the scientific, and radiation- protection community (B.a-36,.E.a-5).
Response: See' the response to comment 3-..3.6.1"..
3.3.6.4 EPA should use the organ weighting factors recommended by ICRP-26
to relate organ risk to whole-body risk (A.a-6, A.a-38, A.a-46, A.b-23,
B.a-6, B.a-14, B.a-17, B.a-46, B.c-11, B.c-21, B.c-22, D-10, E.a-5, E.b-1,
F-2).
Response: We have done so. See the response to comment 3.3.6.1.
3.3.6.5 EPA's weighting factor for gonad dose should be the same as
ICRP-26 (A.a-6, A.a-38, A.b-23,.A.d-13, B.a-17, B.a-53, B.c-11, D-6,
E..a-6, E.b-10). ' ' ' . .
Response: 'Tina! recommendations adopt the ICRP-26 weighting factor for
gonadsV. See the-'responses' to. comments 3.3.2.1 and 3.3.2.2.
- - - . ' - *
3'. 3.6.6 EPA should have set the gonad weighting factor, at least as low as
any of the other weighting factors, i.e., 0.2 or lower (E.a-5).
Response: See the response to comment 3.3.6.5.
3.3.6.7 EPA may depart from the ICRP weighting scheme as long as they are
able to justify their departure on the basis of significant differences in
risk evaluation (A.d-23)-.
Response: See the responses to comments 3.3.2.1 and 3.3.2.2.
3*3.6.8 Application of the ICRP-26 concept of weighted whole-body
equivalent doses for organ doses is not practical and results in
overestimation of individual exposures (E.b-3).
Response: We disagree. The system has been shown to be practical through
its wide international application. We are not aware of any significant
examples of this system leading to an overestimate of effective dose
equivalent or risk.
3.3.6.9 EPA should consider the adoption of separate risk factors for
organs dominant in one sex only (A.a-18).
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Response: . This was considered, but it was rejected as an unnecessary
complication that was not justified by a large enough difference in risk,
and that could encourage sex discrimination. . See the response to comment
2.13.6. . / . '
-3'.3.6r.io '-'The- weight ing /factor of 0.20' for breast is inconsistent with the
"other organ" limit of 3.0 r ems for breast '(B'.a-9) . '
Response: The weighting factor and "other organ" limit address different
types of risk, and therefore need 'not be the same.
3.3.6.11 The EPA weighting factors are unnormalized (i.e., sum to 0.68)
(B.a-17).
Response: This is not true. The commenter evidently applied the weighting
factor (0.08) to only one of the "other organs," instead of to five "other
organs," as indicated in proposed guidance.
3.3.6.12 the stochastic formula would' permit an intake of strontium - 90
,qf- 17'- times.: the. uptake of this substance 'under, the critical organ concept
'' '' "
Response: As illustrated for various radionuclides in Table Bl of the
Background- Report (EPA 520/4-81-003) of our proposed guidance,
computations based on the proposed dose limits and the new
dosimetric/metabolic models result in intake limits that -are higher for
some radionuclides and lower for others. These new models result in an
intake limit 7 times higher for the old critical organ limit for Sr-90.
Only the' additional' factor of two is attributed to the conversion from
critical to weighted organ limits.
We note that the fact that the proposed intake limit for a given
radionuclide may be substantially higher is not a valid reason to permit
otherwise unnecessary intakes or necessary intakes that are not ALARA.
The dose (and intake) limits do not stand by themselves: unnecessary
exposures should not occur; necessary exposures should be kept ALARA; and,
finally the limits should not be exceeded.
3.3.6.13 In the EPA weighting scheme, the thyroid gland is given little
emphasis despite the fact that this organ is as sensitive to induction of
cancer by external radiation as any tissue in the body (A.a-38).
Response: While the thyroid is sensitive to the induction of cancer by
radiation, only a small percentage (about 6% or less) of those cancers are
lethal. On the other hand, mortality for lung cancer and for leukemia
(red bone marrow) is nearly 100%. These differences are considered in the
weighting factors.
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3.3.7 50-YEAR DOSE COMMITMENT
3.3'.7.1 The age of a worker should be taken into account when assigning
dose commitment; for older workers, much of the 50-year dose commitment
will.'occur after;.the .individual, has- died. (E.a-5).
Response:' One purpose of the.committed dose equivalent is to assure
that for the limiting .case of intake ofradionuclides every year during
a 50-year working lifetime, the annual dose received in the 50th year
from accumulated body burdens will not' exceed the annual dose limits.
When workers experience intakes late in their careers it is true they may
never actually receive an entire 50-year dose commitment. On the other
hand, there will also be workers who receive more than the 50-year
committed dose equivalent, because they live longer than 50 years after
intake. It would be difficult to accurately adjust the committed dose
equivalent for each worker, because longevity cannot be predicted. We
have concluded that it is not practical to adjust committed doses
according to age. .(See .also responses to comments 2.8.1, 2.8.2, 2.8.3,
and 2.8.6.)
.:3;..3~7..:2.-';j'I.t ;.is i^eitherv reasonable, nor .justified to assign all of the dose
'from long-lived raidioriuclides to their year of intake, since this is not
the- manner 'in which the dose would actually be delivered (A.b-23, A.d-13,
A.d-22, B.a-24, E.a-5', E.a-7, E.b-5, E.b-6, E.b-7). ' '
Response: -We disagree. The primary purpose of the use of the committed
dose concept is to assign accountability for the future dose that will
accrue to the worker to the situation under which the intake occurs. In
some cases., however, it is- important to also manage committed doses on a
year-to-year basis. For the case of large intakes where the committed
dose equivalent significantly exceeds the limiting values for committed
dose, the final recommendations provide that the doses received from that
intake in subsequent years be considered so that the sum of annual doses
from such intakes and additional exposures do not exceed the annual
limiting values. See also the response to comment 3.3.7.1.
3.3.7.3 The use of annual committed dose equivalent operates to shorten
the working life of a worker by approaching the lifetime dose limit faster
(E.b-9).
Response: The commenter is apparently concerned that the summation of
committed dose equivalents would cause, for long-lived radionuclides, a
lifetime dose limit to be reached (or exceeded) at some time considerably
before the doses were actually received. This would be particularly .
relevant if a worker received large intakes whose committed doses exceeded
a lifetime limit early in his career. If this were the case it would
indeed be necessary to avoid future intake or external exposure to avoid
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an excessive lifetime dose (and hence risk). .This specific issue is moot,
however, since no lifetime dose value is given in the final recommen-
dations. Howeverx the recommendations also contain an applicable
admonition to avoid continued exposure at or. near the limits that has a
similar, objective. . . .
3.3.7.4 Doses should be assigned in advance for each year from intake to
age "6*5 or 70 (A.a-14). ."' "" ' ' ' '
Response: The suggestion that annual doses from actual uptakes be
assigned in advance for each year through age 65 or 70 would entail
burdensome and unnecessary recordkeeping. In addition, it is an arbitrary
assumption that most workers will die (or risk should be neglected) at age
65 or 70. It is not clear why this would be preferable to the present
50-year assumption. See the response to comment 3.3.7.2.
3.3.8' COMBINED INTERNAL AND EXTERNAL DOSES
\:3>3,.'.8..-If.'.,''We. a.re< In--'agreement.'.that ripnuniform exposure should be treated
using a weighted.sum of doses to individual organs (A.a-18, A.a-46,
A.a-49, .A.a-50-, A-.a-Sl, A.b-9, A.b-18, A.c-6, A.d-13, A.d-23, A.d-42,
B.a-3, B.a-5, B.a-33, B.a-34, B.a-46, B.a-53, C-5, C-6, D-4, ).
* . ' '
Response: No response needed.
3.3.S..2. -The additional cost of combining internal and external dose
equivalents is not justified by the decrease in risk or by its technical
validity (A.a-8, A.a-19, A.a-41, A.d-18, A.d-40, B.a-11, B.a-31, B.a-36,
B.a-37, B.a-39, B.a-48).
Response: We disagree. The commenters do not provide a basis for their
assertion that risks for internal and external exposure are not additive.
Current information on occupational exposure of workers indicates that
relatively few workers receive significant doses from both external and
internal exposure to radiation. Thus, the additional cost associated with
informing and protecting the worker on the basis of total radiation risks
is expected to be small.
3.3.8.3 The combination of external and internal dose equivalents using
weighting factors will be difficult and costly to implement (A.b-6,
B.a-14, B.a-32, B.a-33, B.a-48, B.b-7).
Response: The weighting factors are automatically incorporated into ALIs
and DACs, just as they were into the formerly-used MFCs. Thus, it is
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difficult to justify any need for large additional costs. The draft
revisions to 10-CFR 20 regulations of the NRC show that a reasonable
scheme can be devised to combine external and internal dose equivalents.
'See also the response to comment 1.9.2.
.3v3.8.A The guidance regarding internal exposures is difficult to
Interpret and will require, the use' of a-consultant (A.d-6).
Response: Instructions on acceptable practical means for compliance are
expected to be formulated by the regulatory Federal agencies. There
should not be a general need for consultants to interpret new
regulations. See also the response to comment 3.3.8.3.
3.3.8.5 Separate standards on internal and external exposure should be
maintained (B.c-8).
Response: Separate standards, would permit doubling the allowable annual
increment of risk. The intent of new recommendations is to control the
total risk from the. 'sum of both types of exposure.
3.3.8"^6 ' The critical, organ methodology'has been an effective means of
control (E.a-5.). .' .
Response: We agree, in general. However,, the new recommendations take
much more accurate account of the total risk attributable to all
irradiated tissues.
3.3.8.7 A "de minimis" value of internal exposure should be defined,
below which it should not be necessary to combine internal and external
exposures or report the dose (A.a-41, A.d-13, A.d-40, B.a-4, B.a-8,
B.a-14, B.a-15, B.a-27, B.a-48, B.a-53, B.c-20).
Response: To the extent that such practical cutoffs are advisable, we
expect the regulatory agencies to specify them.
3.3.8.8 As a practical matter, EPA should limit the combining of internal
and external exposures to those situations in which an internal exposure
has occurred which exceeds 1/10 of the applicable Radiation Protection
Guide (A.d-42, B.a-5, B.a-6, B.a-9, B.a-10, B.a-32, B.a-33, B.a-46).
*
Response: See the response to comment 3.3.8.7.
3.3.8.9 Separate records should be maintained for external exposure and
internal intake (A.a-41, A.d-40).
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Response: The final recommendations provide that the committed effective
dose equivalent and the quantity of each radionuclide in the body should
be assessed, and recorded for the intake of radioactive materials. In
addition, a summary of annual, cumulative, and committed effective dose
.equivalent.should be provided'annually to workers. However, the actual
details^ of- recordkeeping requirements, are left to the regulatory agencies-
3.3V8.10'' The conservative assumptions Vhich are necessary to comply with
the internal exposure guidance will obviate the utility of any future
epidemiological studies of radiation risk (A.a-10).
Response: It was not an objective of these recommendations to permit
doses large enough to ensure the utility of such studies. In any case,
such studies only require accurate dose information, whether it be from
internal or external exposures, and do not depend upon the implementation
scheme used to assure compliance with the standards.
3.3.8.11 Given the current state-of-the art, we are only able to develop .
an imprecise estimate of organ,-dose (B.a-31,- E.b-7, E.b-9).
Response:..:"We. recognize-;, there'-.are. limitations to the current state of the
art^'but belie-ve.it is adequate to assure proper protection of workers.
3.3.8.12 In implementing the internal- exposure guidance, considerable
care will have to be exercised to assure that the individual's exposure
record reflects the true exposure and not some highly conservative
estimate (B.a-33).
Response: We agree that an individual's exposure record should contain
accurate data, for internal as well as external exposures. Recommendation
8 specifies that the quantity of radionuclides in the body be assessed and
recorded, to the extent practicable, in addition to the calculated
committed dose equivalent. See the response to comment 3.3.8.9.
3.3.8.13 Guidance 3.c is not consistent with 3.a and 3.b; as it reads, it
appears that, two sets of records would be required - one for the "sum of
dose equivalents in the various organs and one for this sum plus the
external dose equivalent (E.b-1).
Response: The comment apparently confuses partial exposures with whole
body exposures. The final recommendations clarify this.
3.3.8.14 There exists no standard method for the calculation of dose to
the breast or bone surface (B.a-9).
Response: Such methods were used to compute the limits for intakes listed
in ICRP Publication 30 (ICRP80) and are described in Part 1 of that report.
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3.3.8.15 Whether or not to require the summation of internal and external
doses is a decision that should be left to implementing agencies (B.a-31).
Response: We agree that, the specific situations which require summation
of internal and external doses should be determined by the cognizant
.regulatory; agency.. See. the response .to. comment 3.3.8.7.
'3-.3.8.16 The new MPCk for uranium Class "Y material would result in the
need to redesign major elements of fuel handling'and processing equipment,
yet it has not been adequately demonstrated that such lowering of limits
is warranted by medical case histories (B.a-16).
Response: The changes in derived limits are the result of more accurate
metabolic/dosimetric models, which show that a given intake of such
material yields a larger dose than formerly assumed. It is not our intent
to await medical case histories for each type of radionuclide before
reflecting such improved knowledge in the MFCs.
3-.3.8.17 -The: requirement to add '. dose-equivalent exposures of organs and
tissues, to whole-body doses is hopelessly complex and likely to be ignored
' ' ' '
Response: We disagree. .Where such addition is required, the weighting
system provides a straightforward methodology that is no more complex than
'current practice. ' ' . '
3.4.
MINIMUM RADIATION PROTECTION REQUIREMENTS
3.4.1
OVERALL APPROACH
Comment s;*
The proposed range requirements will increase paperwork (A.a-13,
A.a-41, A.b-8, A.d-9, A.d-12, B.a-11, B.a-15, B.a-16, B.a-19,
B.a-21, B.a-24, B.a-27, B.a-48, B.b-7, E.a-2,"E.a-5, E.a-7,
E.a-14, E.b-9).
The three-tier system is needlessly complicated and potentially
expensive (A.a-16, A.a-39, A.d-11, A.d-14, A.d-21, A.d-22, B.a-3,
B.a-21, B.a-31, B.a-37, B.a-44, B.c-12, E.a-6, E.a-7).
The range approach would introduce a- degree of administrative
and/or operational complexity not justified by any health benefit
(A.b-10, A.c-13, A.d-9, A.d-38, B.a-6, B.a-11, B.a-15, B.a-17,
B.a-24, B.c-12, E.a-12, E.a-5, E.a-6, E.a-7, E.b-2, E.b-8).
The varying dosimetry requirements for the proposed ranges will
*Note: Joint Response Immediately Following Comments 1-37.
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result in less health physics protection than is currently
provided (A.a-45. A.b-8, B.a-21, B.a-44, E.a-2, E.a-5, E.a-7,
E.a-2, E.b-3).
5. The three-tier system may actually increase total occupational
exposure by eliminating the flexibility in job planning and execu-
'-tion available under, current standards (A.d-9, B.a-48, E.a-5).
6. -The specification of. minimum protection requirements limits the
judgment and flexibility'of qualified experts (A.a-24, A.a-25,
A'.a-27, A.a-28, A.a-29, A.a-30r A.a-32, A.a-33, A.a-41, A.a-52,
A.a-53, A.d-23, A.d-40, B.a-25, B.a-27, B.b-6, B.c-16, B.c-18,
E.b-3).
7. The proposed ranges are not needed (A.a-39, A.a-41, A.b-6,
A.d-19, A.d-23, A.d-28, B.a-6, B.a-32, B.a-37, B.c-21, E.a-6,
E.b-2, E.b-5, E.b-6, E.b-8, E.b-10, F-3).
8. Dose ranges are unnecessary if every exposure is justified and
ALARA (A.a-16, A.d-28, B.a-11, E.a-5, E.a-7, E.a-6, E.b-9).
9. The range approach is unwarranted as workers' will view it as a
calibration of risk (A.d-28, B.a-35).
10. An- expected level of dose for operations, based on optimization
studies, would 'be preferable to the three-tier approach suggested
(A.d-22). : . .
ll. The proposed scheme of anticipated exposure ranges is intended to
-. place the ALARA concept into a. cookbook formulation, for use by
'"'-. ^nohprbfe'ssional-, completely undermining the application of sound
professional judgment (E.b-3).
12. Recommendation 4 contains requirements licensees cannot meet
.(A.a-19, B.c-21).
13. Implementation of Recommendation 4 will lead to program
degradations (A.a-12, A.d-23).
14. Further detailed guidance on exposure of individuals is not
needed (E.a-6).
15. The- concep.t underlying the range approach is inherent in all
existing ALARA programs (A.b-6, A.d-19, A.d-28, A.d-40, B.a-11,
B.a-14, B.a-15, B.a-16, B.a-21, B.a-27, B.a-29, B.a-31, B.a-32,
B.a-36, B.a-44, B.a-48, E.a-6).
16. The emphasis of regulatory requirements should be on ALARA, not
the proposed ranges. This would allow organizations to develop
radiation protection programs best suited to their specific needs
and situation (A.a-45, A.d-9, A.d-18, B.a-24, B.a-36, E.a-6,
E.b-1).
17. It should be made clear that any requirement or model procedures
developed to implement ALARA, including Recommendation 4, are
only for the guidance of federal agencies (B.a-34, E.a-4).
18. What are the criteria to justify the need for work situations
that are expected to make a significant contribution to Range C
exposures? Are cost/benefit analyses required as implied? If so
must they be documented and will they be subject to regulatory
review, inspection, and enforcement? (B.a-29)
19. Justification of Range C work situations must be generic. EPA
should specifically state that it is not its intent to require
case-by-case justifications of each exposure activity (B.a-3,
B.a-6, B.a-17).
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20. Justification of Range C work situations will result in
unnecessary hardship and costs to the nuclear power industry.
The need for'such Range C activities has been historically
demonstrated (B.a-6, B.a-20, B.a746, E.a-2).
21. It is not clear to whom the justification of Range C exposures is
to be addressed (A.d-18, B.a-4, B.a-6, B.a-36, E.b-3).
22i; The;concepts' of ."justification" .and "ALABA". are used differently
in Recommendation 4 than in Recommendations 1 and 2' (E.a-4).
23. Prior regulatory approval of Range C exposures is redundant
and/or unwarranted (B.a-6, E.'b-6, E.b-8).
24. In Range C, what constitutes a "significant contribution to
exposure?" (B.a-4, B.a-6).
25. The requirements associated with Range C will result in increased
collective exposures as more workers are used to perform a.task
(B.a-31, E.b-6).
26. A graded set of minimum radiation protection requirements based
on expected dose in the work place, with specific dose ranges
established by the implementing agencies, is a good approach
(A.b-9, B.a-5, B.a-33, B.a-34, B.a-46).
27. The deterrent effects' of increased justification, supervision,
and monitoring are an administrative method of lowering the
' ' 5 rem/yr limit to-0.5 rem/yr (B.a-3).
28-- Relaxing .the. .personnel .monitoring requirements (Range A) is
' 'r^-mbrally;.:and legally expensive '(A.b-8)-
29.' The proposed Recommendation 4 should be deleted and replaced with
the following guidance: "The appropriate authorities of each
workplace should ensure that a competent health-physics program
is in place" .(A.a-12). " '
30. The varying dosimetry requirements for the proposed ranges will
make it difficult to provide concise, realistic dose assessments
to workers (A.b-8, A.a-18, A.b-18, B.b-7).
31. The ranges provided in Recommendation 4 are detailed administra-
tive requirements for implementing the general guidance and RPGs.
Such administrative requirements should be left to the cognizant
regulatory agencies; they can fashion such requirements to their
needs and practices (A.a-21, A.d-21, A.d-27, B.a-24, B.a-29,
B.a-34, B.a-38, B.c-21, E.a-6, E.a-7).
32. A cost/benefit study should be made and considered before .final
inclusion of this recommendation (A.a-41, A.d-14, A.d-29, A.d-40,
B.a-11, B.c-12, E.a-5, E.a-6). , ' '
33. Imposing minimum radiation protection requirements for different
job categories could hinder new developments in these areas if a
higher range designation is needed (A.d-22).
34. Field inspectors will abuse the three-tier concept (A.a-14).
35. The proposed ranges introduce many new requirements for
occupations in which persons were not previously considered
radiation workers (A.a-10).
36. The effect of the proposed ranges on dosimetry requirements will
result in radiation workers being covered with dosimeters. It is
clearly unworkable (B.c-21).
37. We do not support the proposal for a graded set of radiation
levels within the RPGs (A.c-6).
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Response: The proposed recommendation 4 for a graded set of minimum
radiation protection requirements (MRPRs)does not appear in the final
recommendations. Instead, three broad recommendations provide for (i)
instruction on-basic risk to. health from, ionizing radiation and radiation
protection procedures for workers to avoid and minimize exposure; (ii)
moni-toritig and recprdkeeping. of occupational doses, and (iii) supervision
of,, workers-and. use '!ofv. administrative.control, and reference levels for
carrying out ALARA'programs. Comments'relative to these general topics
that-are-not specific, to the proposed use of a graded set of minimum
requirements in these-areas are addressed under separate headings.
Many of the comments explicitly or implicitly argued that the costs
of MRPRs would not be justified by the health benefits. EPA considered
the costs of such- requirements (EPA83a) and found the cost/benefit ratio
was, indeed, high. The estimated costs were $6-10 million for startup
plus $500-700 million annually. If the MRPRs achieved an average dose
reduction of 25%, this leads to roughly .$40-170 million per death averted.
3.4.2 SUGGESTED'NUMERICAL RANGES
Iv :.iCRF's''working '.levels' A and .&: as reference levels would be pre-
'.'farable'to EPA's ranges. (A.b-15, A.d-21, B.a-7, B.a-19, B.c-20).
2'. The two levels of control (above and below 25%) in the current
regulations are adequate (A.a-lD, A.a-14).
3. The current classification of radiation workers and the general
public, with exposures to each minimized by application of ALARA
by professional health physicists, is adequate (E.b-2).
4. The proposed ranges are too restrictive, preferable values would
be.v Range A: 0.02-RPG; Range B: 0.2-0.5 RPG; and Range C:
-. 0.5-1.0 RPG (E.a-3). .
5. Two ranges, below 0.5 RPG and above 0.5 RPG are all that is
necessary (A.b-6).
6. The proposed ranges should.be replaced with: 0-10%, no records;
10-100% keep lifetime records; above 100% report to the cognizant
regulatory authority (B.a-26).
7. Range A should be eliminated; Ranges B and C are useless (A.a-46,
A.b-16, B.a-7, B.c-20).
8. The ranges proposed are .adequate as ALARA guides (E.b-1).
9. The range proposal would have merit if used to establish a
de minimis category with minimal training and exposure control
requirements (B.a-4).
10. The nuclear power industry is already meeting the requirements of
Ranges A and B, and ALARA programs effectively accomplish
"Justification" of the "Need for work situations which are
expected to make a significant contribution to exposure in Range
C." Therefore the recommended ranges are not justified (B.a-3).
11. EPA should explicitly state that exposures in Range C are not
prima facia evidence of a poor radiation protection program, and
should not be a basis of disciplinary action (A.b-5).
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12. Additional requirements for Range C would effectively limit
exposure to 1.5 rem/yr. The nuclear power industry cannot
function with such a restrictive limit .(B.a-3).
.13. There does not appear to be any rational cost/benefit basis to
restrict Range C exposures beyond'the requirements of a 5-rem
, : annual RPG. (E.a-6) . .-' ' -
14.;'InRange A.^sub^part A» change "justified" activities to
'.'licensed" .activities (E.b-1).
15.. In. Range. B,' sub-part D;.eliminate the word "justified" (E.b-1).
16. The- minimum limit of concern should be half a rem a year; below
that limit no regulations are necessary (A.a-46).
Response: Final guidance does not contain the proposed minimum radiation
protection requirements with suggested numerical ranges. Instead of
numerical ranges, final Recommendation 9 provides for establishment of
administrative control and reference levels, usually below limiting
values, for specific categories of workers or work situations, as dictated
by the situations. See also the response to comment 3.4.1.
'3.4.3 ': INSTRUCTION
3.4.3.1 Workers should be instructed on basic hazards of radiation and
radiation protection principles, and on the specific risks and protection
activities of their work situation (A.a-5, A.a-16, A.a-19, A.d-8, A.d-19,
E.b-1). -
Response: We fully agree and Recommendation 7 provides for this.
3'.4.3.2 Workers do not know the risk; they assume the risks are minimal
(C-9).
Response: Workers exposed to radiation and managers of activities
involving radiation should be instructed on the basic risks to health from
ionizing radiation. See the response to comment 3.4.3.1.
3.4.3.3 Whose version of radiation hazards should be used in instructing
workers? (A.d-15)
Response: A current summary of EPA risk methodology and estimates is
given in the response to comment 1.4.1. This discussion provides an
update to the Background Report (EPA81), issued on January 23, 1981.
Subsequent information should be disseminated by Federal agencies as
appropriate. See also the responses to comments 1.4.10 for somatic or
genetic effects at low levels of radiation, comment 3.8.15 for teratogenic
effects to unborn irradiated in utero, and comment 3.8.51 for hereditary
effects due to irradiation of the gonads of males and females.
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3.4.3.4 EPA must specify the kind of information that workers are to
receive to assure uniformity (A.c-1).
Response: See..the. responses to. c.omments 3.4.3.1 and 3.4.3.3.
.3.4*3.5 SRC licensees'* currently provide detailed instructions on health
risks and protection methods' to all individuals working in or frequenting
"res,tricted. areas" (B-a-29). ' . , ' . .
Response: No response required.
3.4.3.6 Although NRC licensees already have programs, more extensive than
required by EPA's recommendations, there is no justification for such
unreasonable and burdensome requirements to be issued in a memorandum for
the President (B.a-29).
Response: We do not agree that the recommendations for instruction of
workers are unreasonable or burdensome. The fact that NRC requires this,
and have'.not objected appears to demonstrate this.
'IvAiS.^'-'Gbvernment-sponso'red training "iri; radiation safety is appropriate
(A.a-8). . : ; '. -." ''' ' ' ' . .
Response: It is up to Federal agencies in accordance with their statutory
authorities to determine whether or not they sponsor training programs in
radiation safety.
3.4.3.8 EPA should mandate standard training for health workers, to
include- personnel protection, identification, and hazards of radiation
exposures. The requirements of Recommendation 4, being open to
interpretations based on inadequate data, are of dubious benefit to
workers (A.c-8).
Response: EPA has no authority to mandate training programs for health
workers. This is the responsibility of cognizant Federal regulatory
agencies. However, the final recommendations do specify that
occupationally exposed workers be instructed on basic risks to health from
ionizing radiation and on basic radiation protection principles.
3.4.3.9 No instruction requirements are needed for Range A exposures
(B.a-29, B.c-8).
Response: We disagree. All workers with potential for exposure to
ionizing radiation require some instruction on basic risks to health and
on basic radiation protection principles.
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3.4.3.10 Instruction must not leave the impression that doses below a
certain limit are "safe" or "negligible" (A.d-8).
Response: We agree, and believe that this is--clearly stated in the
preamble to the recommendations. -See also the responses to comments
1..6.11, 2.1.11, .2.2.11 and- 3.1.15. .
3.4.3..11 , EPA should" address- the issue, of. the information flow between
plant management and workers (A.a-5).
Response: Final, recommendations provide the basic objectives for
instruction, monitoring, recordkeeping, and supervision related to. this
matter. Federal agencies will stipulate the necessary regulatory detail
for implementation of these recommendations.
3.4.3.12 The need for financial support for education and training
programs in radiation protection should be considered (A.b-11).
Response: The substance of this comment is outside the scope of Federal
guidance, the Federal regulatory agencies implementing the guidance may
examine the.need-for.financial support 'of education and training programs
in- accorda-nce with:-their statutory-"responsibilities.
3.4.4 MONITORING AND RECORDKEEPING
3.4.4.1 Workers should be monitored and detailed records of all doses be
maintained (A.a-16, A.a-38, A.c-4, A.c-8, C-4, C-6, C-7, E.a-3, E.a-5).
Response: Recommendation 8 specifies that there be monitoring of workers
and exposure recordkeeping appropriate to insuring conformance to the
recommendations. This includes the maintenance of a cumulative record of
lifetime dose equivalents for each worker. However, individual monitoring
and recordkeeping for all potentially exposed workers, without exception,
could lead to substantial expenditures in many work situations without the
possibility of increasing worker protection or benefits. Federal
regulatory agencies will specify criteria for determining when monitoring
and recordkeeping are required for individual workers. Such criteria,
however, do not prohibit employers from providing such services to workers
even though not required by regulation.
3.4.4.2 Maintenance of lifetime dose records implies a central records
repository; EPA should clarify its intent (B.a-22, B.c-20).
Response: Establishment of a national central repository for occupational
radiation exposure records is not within the scope of the subject
guidance. See the response to comment 1.10.8.
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It appears useful to clarify here the concept of lifetime dose as
it is a focal point of many comments. "Lifetime dose" means accumulated
dose from' all occupational exposures. Current regulatory interpretation
of the 1960 guidance requires maintenance of a lifetime dose record if a
..worker.is to. be. permitted to receive, in a calendar quarter, a whole body
dose in: excess of' 1.25. rems (up to the...3.0 rem limit) as proof that such a
dose"'woul'd' not- -lead'' to exceeding- the accumulated dose condition of 5(N-18)
rems,' where N is the worker's age in years. 'These .recommendations,
however, specify a simple annual "limit of 5 rems-j and there is no explicit
lifetime dose limit. However, we do not intend that this be interpreted
to mean that "lifetime dose" is now considered irrelevant. Such records
are important in limiting accumulated lifetime risks. Thus, we encourage
the maintenance of lifetime occupational dose records.
3.4.4.3 Expanded monitoring in the two higher ranges does not appear to
be justified (E.a-5).
Response: The proposed recommendation.4 and its monitoring/recordkeeping
requirements for dose ranges do not appear in the final recommendations.
See also the. .response to comment ..3.4.4.1. . . .
3.4.4.'4 /Eliminate"the- additional" monitoring and" recordkeeping
requirements in-Ranges B and' C (E.b-1).
Response: See the response to comment 3.4.4.3.
3.4.4.5 Any worker in exposure Range A should be entitled to 12 months of
employer-paid monitoring to satisfy himself that he is not being exposed
'beyond the limits (A.a-36).
Response: The Federal regulatory agencies will specify minimum monitoring
requirements. If an employee believes additional, monitoring is warranted,
that request should be made to the employer, the cognizant Federal
regulatory agency, or the employee's union or professional organization,
as appropriate. See also the' response to comment 3.4.4.1.
3.4.4.6 Requiring lifetime monitoring and recordkeeping once a worker has
been exposed in Range C places an unfair burden on future employers
(A.d-12).
Response: The burden of maintaining an exposure record is very small. In
any case, except for intake of radionuclides that exceed the limiting
values and require future exposure management of the worker, the final
guidance should not place new monitoring or recordkeeping burdens on
future employers beyond those already in place. See also the response to
comment 3-.4.4.1.
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3.4.4.7 Guidelines for monitoring should be evaluated on the basis of
task-by-task risk assessments (A.d-8).
Response: The details of such guidelines; if justified, would be
established by the Federal regulatory agencies.
3.4.4.8 The monitoring program required for Range B exposures will cover
too many workers and 'be 'too* expensive. (B.c-14).
Response: See the responses to comments 3.4.4.1 and 3.4.4.3.
3.4.4.9 The minimal monitoring requirements for Range A exposures could
fail to detect some potentially hazardous levels of radiation from
unexpected contamination problems (A.a-36).
Response: See the response to comment 3.4.4.1. It is the responsibility
of Federal regulatory agencies to .specify criteria for monitoring
sufficient to detect actual and potentially hazardous levels of radiation
for-.all sources or .activities, that are included within their statutory
authority.- ' ' ' . . .
3'. 4.4.10 .A significant effort .would be - required to upgrade records
programs to comply with the three-tier system (B.a-6, E.a-5, E.a-7).
Response: See the responses to comments 3.4.4.1 and 3.4.4."3.
3.4.4.11 .Lax recordkeeping requirements will defeat all attempts to
conduct low-dose epidemiology studies (A.b-23, A.c-4, C-4, C-6, E.a-5,
E.b-1).
Response: We do not agree that the proposed (or final) recordkeeping
recommendations encourage laxity. If the comment is suggesting additional
recordkeeping'beyond that required for administration of radiation
protection programs for the purpose of low-dose epidemiology studies, that
is beyond the scope of the subject guidance.
3.4.4.12 EPA's proposal will result in escalated monitoring and
recordkeeping requirements without any justification being shown for such
actions (A.d-40, B.a-29, B.a-50, E.a-5).
A
Response: We do not agree. The cognizant Federal regulatory agencies
have sufficient experience in these matters to assure justified
requirements. In addition, the public and affected parties will have an
opportunity to assess and comment on proposed monitoring and recordkeeping
regulations. See also the response to comment 3.4.4.1.
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3.4.4.13 The burden of maintaining the required records would be lessened
if the major dosimetry services would establish and share exposure data
bases (A.b-5). .
Response: This matter is not within the scope of the subject guidance.
3.J4-4.14 The varying.recordkeeping "requirements are totally unworkable in
the-case of the transient worker (B.a9). ..--..
Response: We are confident that the final recommendations are now
flexible enough to permit the Federal regulatory agencies to- provide
"workable" recordkeeping requirements for all significantly exposed
workers (transient and otherwise). See the responses to comments 2.3.1
and 2.13.8.
3.4.4.15 Records of annual exposure levels, should be sufficient.(B.a-10).
Response: Recordkeeping is required'to demonstrate compliance with the
limiting values of dose as well as other parts of the recommendations.
Records of annual exposure levels may or may not accomplish this, and thus
each Federal.-regulatory, agency must make this determination. See the
responses" ctd; comments .3.4.. 1.and' 3:. 4'. 4.1.
3.4.4.16 How long must Range B exposure records be maintained (B.a-22)?
Response: At least long enough to compile lifetime dose records.
3-.4.4.17 EPA's guidance should include a requirement to maintain
(lifetime) records of consumer's medical and dental exposures (A.c-8, C-5,
C-7, C-8, D-5, E.a-3).
Response: Medical and dental exposures are not within the scope of the
subject guidance.
3.4.4.18. Workers should have access to all their dose records (A.d-8,
A.c-1, A.c-4, A..C-8, C.2).
Response: Recommendation 8 provides that workers receive a summary of
annual, cumulative, and committed effective dose equivalents on no less
than an annual basis and further information upon their request. See also
the responses to comments 1.10.3 and 3.4.4.1.
3.4.4.19 All workers subject to recordkeeping should be furnished
quarterly dose and cumulative lifetime dose records on a quarterly basis
(C-5).
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Response: In addition to specifying recordkeeping requirements,- the
regulatory Federal agencies will also specify requirements for keeping
workers informed of their radiation exposure status on at least an annual
basis, consistent with these recommendations. More frequent informing of
workers could be specified by the regulatory agency. See also the
response to-, comment 3.4.4..1.-..
3.'4.4".20 "All workers in the nuclear industry-should receive a current
copy of their annual and lifetime accumulated whole body radiation
exposure records from their employers on an annual basis (C-8).
Response: See the responses to comments 3.4.4.1 and 3.4.4.19.
3.4.4.21 Some workers have trouble getting their dose records (C-5, C-8).
Response: We are not aware of circumstances where occupational exposure
information.can properly be .withheld from the worker. Any such current
problems should be eliminated when these recommendations are implemented.
See also. the. responses-to .comments 1.10..3,.- 3.4.4.1, 3.4.4.18, and 3.4.4.19.
3.4.4.'22 ""individual' monitoring/ as defined in 10 CFR 20, 2(b)(l),. is
inappropriate for assessing internal exposures in Ranges.B and C (A.a-12)
Response: Regulation-s of the Federal agencies (for example, the cited
Section of 10 CFR 20 of the NRC) will have to be revised to conform with
final Federal radiation protection guidance. See the responses to
comments 3.4.4.1 and 3.4.4.3.
3.4.4.23 Internal and external exposure records should be maintained
separately (A.a-41).
Response: Although the final recommendations provide numerical limits
that apply to the sum of the dose from both external and internal
exposures, they also call for separate recording of internal and external
exposures. The appropriate means of keeping records to demonstrate
compliance will be detailed by the regulatory agencies. See the responses
to comments 3.4.4.1 and 3.4.4.22.
3.4.4.24 Monitoring should be done by qualified personnel (A.a-16)
Response: No response required.
3.4.4.25 EPA should include in its guidance criteria for notification of
workers exposure levels (E.a-6).
Response: Recommendation 8 specifies that workers should be so advised.
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3.4.4.26 Lifetime dose records should be maintained for all radiation
workers (A.a-38, A.a-45).
Response: We believe final recommendations .are in. agreement with this
comment. Final .recommendation 8 requires "Appropriate monitoring of
workers and the work:, placed should, be performed .and records kept to ensure
conformance with 'these'recommendations..iMaintenance of a cumulative
record of lifetime occupational doses for each worker is encouraged."
Such records would be useful to both employer and employee if questions of
a worker's occupational dose are raised at some later date.
3.4.4.27 A 100 rem lifetime limit will require employers to maintain a
complete exposure record for each employee (A.a-19).
Response: We agree that this would be the case if and when a lifetime
limit is adopted. However, it would not be unreasonable for employers to
maintain complete exposure records even without a lifetime limit. See
also the response to comment 3.4.4.26.
.3.4x4.28. Lifetime dose .records within the current limits are meaningless
' ''
Response: We' disagree. Such dose records establish that workers do not
exceed standards and also the levels of dose actually received. These
dose levels are important to any subsequent calculations of probability of
causation for cancers that may occur for individual workers.
3.4.4.29" Recommendation. .4 .h appears to require the maintenance of a
lifetime record even after an employee terminates employment. This places
an unreasonable burden on the employer; this requirement should be
reconsidered (A.a-19, B.a-6).
Response: We believe that lifetime dose records should be maintained by
someone for some time after an employee terminates employment and that
such a requirement can be formulated by the cognizant regulatory agency
without an unnecessary or unreasonable burden on employers. Without such
record maintenance it would seem impossible for either the employee or
employer to accurately establish radiation exposures for any given period
of employment. The actual location for maintenance of such records would
be determined by the cognizant regulatory agency. This determination
should include consideration of benefits and costs. Recent cases of
litigation would appear to confirm the desirability of maintaining all
exposure records, as there are potentially large benefits from being able
to document what doses a worker did or did not receive. See the responses
to comments 3.4.4.26 and 3.4.4.28.
3.4.4.30 What is the rationale for strongly encouraging lifetime records
for workers exposed in Range B (A.b-5)?
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Response: There is good reason for keeping lifetime records of monitored
workers at all levels of exposure. Even where workers receive no
measurable exposure lifetime records provide corresponding documentation
to. reassure the worker and to ve-rif y the level of protection provided by
the employer's radiation protection .program. See also the responses to
comments 3\4.4.26, 3.4.4.28 and-3.4.4.2.9.
! v '.'I.
3.4.4-31 The 100.rem lifetime limit would.require obtaining a worker's
exposure history before Range B exposures would be allowed (A.a-1.9,
B.a-29).
Response: We would agree that if and when a lifetime limit is
established, it would require that a worker's exposure history be obtained
to properly manage future exposure. However, the implementation of such a
lifetime limit by regulatory agencies would have to include provisions for
some appropriate and timely transfer of worker exposure histories.
3.4.5 . SUPERVISION
-3v4Y5'.lT'' 'Increased'on-'the-job supervision does not appear to be justified
(B..a-4> B.a-29, B;b-7, E.a-2, E.a-5).
Response: This matter is left to the discretion of regulatory agencies.
3.4.5.2 The radiation protection supervision requirement should be
clarified so that it is not interpreted to require the physical presence
of the"supervisor during 'the job (B.a-33, B.a-37, B.a-46, E.a-2).
Response: The intent of the proposal was not that radiation protection
supervision involve exposure, unless that was essential to achieve
adequate control of radiation protection.
3.4.5.3 A requirement that professional radiation protection personnel be
available and empowered to do the necessary job would be preferable to the
proposed guidance calling for these professionals to be in the workplace
(A.d-13).
Response: See the response to comment 3.4.5.2.
3.4.5.4 Having supervision present (under Range C) will result in
increased exposures (A.a-19, A.a-21, B.a-17, B.a-37, B.c-12).
Response: See the response to comment 3.4.5.2.
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3.4.5.5 Part d of Recommendation. 4 should be clarified. As presently
written it could be interpreted as requiring certified health physicists
to be stationed in all areas where individuals may receive in excess of
0.5-rem/yr (B.a-5, B.c-23).. .
Response: See the response to comment 3.4.5.2.
.3..4.S.6 Supervision beforehand during jobs in'Range- C will increase costs
(A.a-21, B.b-7). ''..'
Response: Such supervision should already be in place at such high
doses. If they are. not, costs may indeed increase.
3.4.5.7 The term "professional radiation protection supervision" must be
clearly defined before the guidance is issued (A.b-11, A.b-23, B.c-23).
Response: The final recommendations do not include the specific elements
of proposed recommendation 4 on minimum radiation protection requirements
for supervision'in dose ranges. They do, however, contain a broad
recommendation on radiation-protection supervision.
3.4.5.8 Recommendation-4.f should "be rewritten to read:"... and provide
management supervision and radiation protection personnel review before,
and frequent surveillance while such jobs are undertaken, to assure that
collective and individual exposures are ALARA" (A.d-42,-B.a-10). '
Response: See the response to comment 3.4.5.7..
3.4.5.9 Range A would require professional radiation protection
supervision to assure exposures are justified and ALARA. This is
unnecessary since doses in this range should be considered de minimis
(B.c-4, B.c-20). - .
Response: Doses below 500 mrem/yr are clearly not "de minimis"."
Recommendations 1 and 2 are intended to apply as fully to such doses as to
higher doses.
3.4.5.10 Range A would require professional radiation protection
supervision to assure that all exposures are justified and ALARA (B.a-39).
Response: We agree. However, such supervision could be managed on a
generic basis.
3.4.5.11 Guidelines for supervision should be evaluated on a task-by-task
basis (A.d-8).
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Response: In.some cases, yes. In others, more generic treatment may be
adequate and appropriate.
3.4.6- LIFETIME DOSE
3..4*6«1. .The 100. rem lifetime limit .is;unnecessary (A.a-18, A.a-41,
A.a-46, A.b-15, A.b-16, A.b-26, A.d-9, A.d-21, A.d-29, B.a-3, B.a-6,
B.a-9, B.a-17, B.a-21, B.a-22, B.a-31, B.a-44, B.a-46, B.a-48, B.a-53,
B.c-12, E.a-4, E.a-5, E.b-6, E.b-7, E.b-8, E.b-10).
Response: We agree. Since few workers have historically received more
than a 100 rem lifetime dose up to the present time it is unlikely,
according to present levels and trends of exposure, that workers currently
entering the work force would exceed such a lifetime dose.
3.4.'6.2 The need and benefits of 'the 100 rem lifetime limit are unclear
(A.a.-8, A.a-13, A.a-<39,. A.b-22, A.d-fr, A.d-22, B.a-4," B.a-20, B.a-23,
B.a-24', B.a-27, B.a-32;' B:a-33, "B.a-34, B.a-37, 'B.a-39, B.a-46, B.c-12,
B.cr20, E.a-7.,;:.E,b-5, F-l).. . . .-.;...... ..'...
- "- ""'*' ,-j "".-**;?-"'" .'-'"' f «: *.*'., .-.'-'' .,..,"--" - .. -
. . ; .*. ''«.- ..'.. -, ,.--.-.
Response: The benefit"of a lifetime 'limit is to clearly limit the maximum
risk to an individual worker. See the response to comment 3.4.6.1 for the
question of need.
3.4.6.3 The 100 rem lifetime limit would result in legal problems by
making- a worker unemployable (A.a-8, A.a-13, A.a-39, A.b-22, A.d-6,
A.d-22, B.a-5, B.a-6, B.a-8, B.a-14, B.a-17, B.a-20, B.a-22, B.a-23,
B.a-24, B.a-27, B.a-29, B.a-30, B.a-32, B.a-33, B.a-34, B.a-36, B.a-39,
B.a-46, B.a-48, B.a-50, B.c-21, C-l, C-2, E.a-5, E.a-6, E.b-2, E.b-5,
E.b-6, E.b-7, E.b-10).
Response: The issue is moot as no lifetime limit is adopted in final
recommendations. However, a recent EPA analysis of accumulated doses of
terminated workers indicates that such a limit would not affect even the
currently highest exposed workers, such as those found in the nuclear
industry (Ku84).
3.4.6.4 The 100 rem lifetime limit would adversely impact the nuclear
industry by unnecessarily restricting the availability of skilled workers
(A.d-18, B.a-1, B.a-3, B.a-20, B.a-21, B.a-27, B.a-32, B.a-33, B.a-36,
B.a-37, B.a-44, B.a-46, E.b-2).
Response: See the response to comment 3.4.6.3.
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3.4.6.5 Some formula to adjust the previous exposure of workers is
necessary to protect the livelihood of veteran workers when a lifetime
dose i's established (A.d-5, A.d-12, B.a-7, B-c-20, C-8, E.a^3, E,b-3).
Response: We agree. However, see also the response to comment 3.4.6.3.
3.4.6.6 If the annual RPG is appropriately derived, there is no need for
a-lifetime limit (.A.d-13, B-.a-33j- B.a-35, B.a-46, B.a-53, E.a-4).
Response: This is not the case. The justified need for allowing a
maximum annual dose to a worker in any given year does not.justify
allowing that maximum annual dose in other years without considering the
equity of utilizing other workers and other alternatives. Because the
maximum annual dose allowed workers would result in an unacceptable
level of risk if received every year of a working lifetime, a lifetime
limit could become necessary if such patterns of worker exposure should
develop.
3".4..6.7 .The 100.rem lifetime .'limit is. chosen, to assure that the risk of a
maximum exposed radiation worker is comparable to the average risk in
rothe.r; .industries* This .is not!''a .valid method, for making the comparison
(A':b'-i; A'.d-lK-B^a-^''B'^-22^B.a-3l, B.a-33, B.a-37, E.a-6).
Response: This is not true. According to the relative risk model, the
lifetime risk of death for workers receiving 100 rems uniformly spread
over the age range 18 to 65 would be more than three times larger than the
average accidental death risk for all U.S. workers.
3.4.6.8''. The proposed 100 rem lifetime limit is appropriate (C-5, C-8,
E.b-3).
Response: No response required.
3.4.6.9 The lifetime limit should be less than 100 rems (A.a-3, A.a-38,
C-8).
Response: The comment is moot since the final recommendations do not
include a numerical lifetime dose objective. However, the final
recommendations encourage the maintenance of lifetime (accumulated) dose
records for workers and stipulate that "continued exposure at or near
[the] limiting values for substantial portions of a working lifetime
should be avoided."
3.4.6.10 The lifetime limit should be restricted to 10 rems (A.c-6).
Response: See the response to comment 3.4.6.9,
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3.4.6.11 The proposed 100 rem lifetime limit would increase the risk of
genetic damage (A.a-19, A.b-16, A.b-20, A.d-18, B.a-7, B.a-21, B.a-29,
B.a-30, B.a-31, B.a-32, B.a-44, B.a-48, B.b-1, E.a-5, E.a-6).
Response: We disagree. A lifetime limit would neither encourage the
increase nor cause the increase of genetic or somatic damage. See also
the ^response-; to .comment 3.4; 6.. 9>.-.. ./:./ -,.-. :- ....
3.4.6.12 The proposed 100 rem lifetime limit fails to consider the
decreasing risk of radiation exposure with increasing age. As a result,
total risk- might be increased if workers receive most of their lifetime
risk early in their careers (A.a-8, A.b-20, A.d-18, B.a-17, B.a-30,
B.a-33, B.a-37).
Response: We agree. However, see the response to comment 3.4.6.9.
3.4.6.13 Exposure beyond 100 rems should be on the basis of the worker's
informed consent (A.b-5, E.a-6).
Response r See .the'response to comment'3.4.6.9.
3.4.6.14. Workers_approaching 100 rems accumulated exposure should be
informed 'and restrictions of future doses decided on a case-by-case basis
(C-l, E-.b-2). . .
Response: See the response to comment 3.4.6.9.
3.4.6.15 Eliminate the 100 rem lifetime limit and replace it with the
following guidance: "Maintain lifetime doses ALARA. The accumulated dose
of individual workers should be managed so that it is less than a
specified, reasonably achievable ALARA goal. Where workers have, already
accumulated more than 50% of this lifetime limit due to work under
previous regulations, they should be allowed to accumulate additional
exposures up to 100% of this lifetime limit" (E.b-1).
Response: See the response to comment 3.4.6.9.
3.4.6.16 Does the 100 rem lifetime limit include emergency exposures?
(B.a-32, B.a-38, E.a-5).
Response: See the response to comment 3.4.6.9.
3.4.6.17 Employers might use lifetime dose histories to discriminate
against workers with significant exposure histories (B.a-8).
Response: See the response to comment 3.4.6.9.
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3.4.6.18 The 100 rem limit could lead, to dose falsification by workers in
high exposure industries (A.d-6).
Response: . See the' response to comment 3.4.6.9.
31.4'.6'.T9. Lifetime dos'e 'records for all radiation workers must be
available to all radiation workers ..(C-2).
Response: See the response to comment 3.4.6.9.
3.4.6.20 This recommendation could give rise to claims of apparent past
negligence by the government for those workers who have exceeded the
proposed lifetime limit (E.a-5).
Response: See the response to comment 3.4.6.9.
3.5 , RADIOACTIVITY INTAKE FACTORS .
.3"'.'5-.T'''" EPA"dbesnot 'present sufficient 'justification for a change from
the current MFCs to the proposed RIFs (B.a-3, B.a-4, B.a-27, B.c-21,
E.a-2). ''. '
Response: Final recommendations adopt the internationally-accepted
approach of ICRP Publication 26 (ICRP77), where the same basis ( i.e.
committed dose) used for deriving MPCs and the proposed RIFs or final ALIs
is continued. In the ICRP-26 weighting system, the ALI (Annual Limit on
Intake) replaces the RIF-. '
Some discussion of old and new acronyms and their relationships
appears useful here. The DAC (derived air concentration) for a
radionuclide under final recommendations is the counterpart of the old
MFC. Thus, for inhalation of radionuclides, the DAC or MFC
(microcuries/cc of air) of a specific radionuclide multiplied by the
volume of air inhaled during a working year (2.4x10' cc of air/working
year), by "Reference Man" (ICRP75) gives the ALI (microcuries/working
year) of that radionuclide.
3.5.2 There is no need for the RIF approach, nor are there any benefits
to be derived from it (A.a-39).
*
Response: We disagree. Although final recommendations adopt the ALIs
rather than RIFs, as a result of adopting ICRP-26 weighting factors, both
the ALI and RIF are based on the same committed dose concept used for the
former MPCs. See also the response to comment 3.5.1.. As a practical
means of compliance (with the basic dose limits), presented in Note 2 of
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our proposed guidance, use of the RIF greatly facilitates the control of
workplace exposures to assure that the dose'limits are not exceeded. The
same is true of the ALL
3.5.3 Exposure" should not be" regulated through use of RIFs (E.b-2).
Response: Secondary limits,'such as RIFs or ALIs, provide a practical way
to implement the basic, limits. .See. also the. responses to comments 3.5.1
and 3.5.2. Although the basic limits are expressed in units of dose
equivalent or committed dose equivalent, secondary limits (ALI or RIF) are
derived for practical radiation protection in terms of quantities that can
be measured. These secondary limits reflect the use of models which
relate a radionuclide quantity with the corresponding dose equivalent to
an adult Reference Man. From secondary limits, a derived limit, such as
the DAC, can be calculated which expresses the basic limit in terms of a
limiting environmental condition for Reference Man.
3.5.4 The proposed use of Radioactivity Intake Factors will involve more
.operational problems in- implementation then the continued use of
Radioactivity 'Concentration Guides (RCGs) (A.b-11).
'Response:" ~We. disagree."" ^Both'. secondary limits. (RIFs and ALIs) and derived
limits' (RCGs or DACs) have their necessary and practical use in
operational radiation protection. See the responses to comments 3.5.1,
3.5.2, and 3.5.3.
3.5.5 It is more practical to regulate and monitor concentrations and
contamination rather than intake (A.b-23).
Response: See the response to comment 3.5.4.
3.5.6 The added workload required by Recommendation 5 is not justified by
the potential radiation exposure reductions (B
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3.5.8 Recommendation 5 should be covered as a part of Recommendation 3
(A.a-41) or as a part of Recommendation 4 (B.c-20)..
Response:. Proposed recommendation' 5a- appears in final recommendations as
a note. .See the .response to comment 3'.5.6.
3.5.9" .The-use: of-Radioactivity Intake Factors is an improvement over the
current practice of basing internal exposure limits on airborne
concentrations (B.a-5, B.a-33, B.a-46, B.a-53, D-2).
Response: We agree, for purposes of meeting the primary limits of dose,
that the determination of actual radionuclide intakes is a better measure
of compliance than the measurement of airborne concentration to which the
worker was exposed.
3.5.10 Part b.of. Recommendation No. 5 is not consistent" with ICRP
Publication 30.and'adds an additional element of confusion to radiation
protection (A.d-18, B.a-33, B.a-36, B.c-22, E.b-1).
.Response: Part b of. proposed recommendation 5. has been deleted. See the
. response* to commejit 3~5v;6-v' ....; ;.- ,'.'.;:/'.....;.. '-' : .
3.5.11 Recommendation 5.b contradicts Recommendation 5 and is ambiguous
(A.a-19). . . ' * __ -
Response: See the responses to comments 3.5.6 and 3.5.10.
3.-5.1'2 We vigorously -support Recommendation 5b, in part because of the
large uncertainties -in the organ weighting factors, w^ (C-5).
Response: When changes in metabolic and dosimetric models lead to higher
ALI or DAC values, the application of ALARA should determine whether
actual levels of exposure need to increase. Therefore, this
recommendation has not been retained in final recommendations. See the
response to comment 2.2.8.
3.5.13 Is it the intent of EPA to make the derivation of the RIFs the
responsibility of each user? (A.b-5, A.d-11, A.d-14, A.d-29, A.d-40,
B.a-33).
Response: We did not intend that users derive their own RIF values. It
was our intent to furnish that set of values. Since we have adopted the
ICRP Publication 26 basic system of dose limitation for final guidance,
the ALIs (annual limit on intake) replace our proposed RIFs, and currently
acceptable values of the ALIs are available in ICRP Publication 30.
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3.5.14 Will EPA provide individual RIFs for each situation, each
employer, and each job classification? (A.d-11, A.d-14, A.d-29, A.d-40).
Response: No.- EPA will provide or- reference ALI (RIF). values based on
Reference Man. It-is permissible to use more specific metabolic and
dosimetric models 'in those situations where the. necessary data are
available. See the: response to- comment 3.5.13. .
3.5.15 EPA should either derive and publish RIFs or use ICRP's ALIs
(B.c-11, E.a-4).
Response: See the response to comment 3.5.13.
3.5.16 EPA should make the RIFs numerically equal to ICRP's ALIs in ICRP
Publication 30 (A.a-1, A.a-49, A.a-50, A.a-51, A.d-13, A.d-18, B.a-29).
Response: See the response to comment 3.5.14.
3.5.17 EPA should permit the. use of site-specific RIFs where actual data
arer-a.y.ailable::(B..a-:33,;Bia-46)..--.:; :.; . .:/.: . ... .-
Response: This is EPA's intent. . However,. Federal regulatory agencies
will'determine the specific criteria £or such use of site-specific ALIs.
Modifications to the. ALIs in KRP-30 could be made for specific
individuals where there is adequate metabolic/dosimetric data available to
modify the model data assumed for Reference Man (see ICRP Publication
23). See the response to comment 3'.5.14.
3.5.18 A consistent methodology, representing equal risks, should be used
in deriving RIF values (B.a-22).
Response: This has been done Tsy adopting the ICRP-26 basic system of dose
limitation for final recommendations.
3.5.19 EPA uses complex mathematical models which may not be understood
by the average Radiation Safety Officer (A.d-6).
Response: The mathematical formulations recommended are not complex.
3.5.20 Is a "Radioactivity Concentration Guide" the same as a
"Radioactivity Intake Factor" divided by the amount of air or water an
individual ingests in a year (A.a-12).
Response: Yes. See responses to comments 3.5.1, 3.5.2, and 3.5.3 for
further discussion of the terms used in final recommendations.
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3.5.21 The RIFs appear to be unnecessarily restrictive; there is no valid
reason to arbitrarily reduce the airborne uranium concentration limit by a
factor of 10 below its current value (B.a-14).
Response: The values for. secondary limits (ALIs or RIFs) and for derived
limits :(DAGs or MFCs) are not arbitrarily lowered or raised. They have
chaiiged: due-: to-improved knowledge, of metabolism and dosimetry. The ALIs
and. DACs are the'result'of computations based 'on the models and parametric
values described .in ICRP-30. .See also .the responses to comments 2.2.8,
3.'5.6, and 3.5ll2. ' ' .
3.5.22- EPA's substitution of the terminology "Radioactivity Intake
Factor" for ICRP's "Annual Limit of Intake" is unnecessary and confusing
(A.a-1, A.b-6, A.d-13, A.d-18, B.a-29, B.a-36, B.c-22, E.a-6).
Response: The proposed Radioactivity Intake Factors (RIF) were based on a
system similar, but not identical, to that of ICRP's "Annual Limit on
Intake" (AH), because -they depend on a somewhat different set of organ
weighting factors. 'Hence, the RIF is not the same as an ALL To use the
same term would lead to confusion. As the basic system- and numerical
limiting d.oses irr ICRP-26 have been adopted in final recommendations, the
; secondary limit, will now be- called, the ALL .
3.6 LIMITS BELOW THE GUIDES
3.6.1 If the recommendations of ICRP, NCRP, and EPA's guidance are
valid, there is no need for Recommendation 6 "(A.a-14, A.b-5, A.d-12,
A.d-40,; B.a-14, B.a-15, B.a-27, B.c-12, B.c-14).
Response: We do not agree. Such additional limitations are part of the
current framework of radiation protection programs, including the
recommendations of the ICRP. Thus, the final recommendations provide for
establishing- administrative control levels below the specified limits by
agencies or management. Such control levels are called "authorized
limits" by the ICRP (See paragraph 148 of ICRP Publication 26) and may be
established through an optimization or ALARA process.
3.6.2 Recommendation 6 defeats the purpose of having a lead agency set
standards (A.a-41, A.d-14, A.d-24, A.d-40).
Response: We do not agree. The intent of this recommendation is to
further facilitate the elimination of unnecessary exposure and the
achievement of ALARA. See the response to comment 3.6.1.
3.6.3 Allowing federal agencies to set lower limits will lead to
confusion and undermine the confidence of workers and the public in the
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'safety provided at the proposed limits (A.a-10, B.a-11, B.a-21, .B.a-44,
B.b-7,. B.c-20).
Response: We-disagree- On the basis of the linear nonthreshold
hypothesis., risks are proportional to dose, and there is no completely
risk-free level' of radiation exposure.. The recommendations therefore
encourage, administrative control levels below the limiting values to be
established by agencies or management, on the basis of generic ALARA
findings. Setting .of' such administrative levels has'been a common
practice in many user activities. This practice has not led to confusion
or to undermining the confidence of workers and the public. See also
response to comment 3.6.1.
3.6.4 We are opposed to Recommendation 6, as it would give regulatory
agencies authority to establish arbitrary and discriminatory guides
(A.b-15, A.d-11, A.d-14, A.d-18, A.-21, A.d-40, B.a-7, B.a-19, B.a-27,
B.a-36, B.b-7, B.c-20, D-2).
Response: We do not believe that agencies would establish capricious or
discriminatory regulations. If this, were the case, administrative
remedies are-available.
3.6^5" We are opposed.to .Recommendation 6, as it gives regulatory agencies
license to legislate ALARA (B.a-7, E.a-2). - ' '
Response: That is the intent, when it is justified. The intended use of
administrative control levels is to further ensure that the objectives of
that guidance, including ALARA, ar§ met. See the responses to comments
3.6.1. and 3.6.4.
3.6.6 Establishing limits lower than the proposed guides should be an
administrative option of the licensees, not a regulatory option of federal
agencies (A.a-14, B.a-5, B.a-33, F-2).
Response: Radiation control measures should be determined and used by
both management and regulatory authorities, as appropriate. See the
responses to comments 3.6.1, 3.6.3, and 3.6.5.
3.6.7 Allowing federal.agencies to set lower limits will lessen the
willingness of licensees to employ ALARA principles (-B.b-7, B.c-20,
B.c-22).
Response: If this were so, then it would imply that the system of dose
limitation, which depends on both the existence of limiting values and
application of ALARA, is not feasible. This would imply the need for low
enough limiting values so that ALARA is not needed. We hope this is not
the case.
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3.6.8 The effect .of agencies setting lower limits will be to penalize
licensee's with good.radiation protection programs (B.a-33, B.a-46,
B.c-20, B.c-22).. '
Response: If a licensee's "radiation"protection program is indeed a "good1
one, it would'not be adversely affected by such limits.. See also the
responses, "to comments' .3..S.l'-and 3.fr.7. ". . ^ " ...
3.6.9 Lower limits, set by regulatory agencies that do not- fully
understand the operational requirements of an activity, could cripple
operations by denying needed flexibility (A.a-41, A.d-12, A.d-15, A.d-40,
E.b-9).
Response: Regulatory agencies should be fully cognizant of the
operational requirements of the activities they regulate. See the
responses to comments 3.6.1, 3.6.3, and 3.6.8.
3.6.10 Many federal agencies do not have the expertise to set limits
based on different categories of workers or work situations. If this
recommendation is retained, it must specify that a certified health
physici.st. make.--the;, dete'rminatfons upon which-.the limits are based (E.a-3).
Response: The establishment of administrative control levels should be
carried out by competent authorities, whether Federal regulatory agencies
or management. See the responses to comments 3.6.1, 3.6.8, and 3.6.9.
3.6.11 Conscientious application of ALARA makes Recommendation 6
unnecessary (A.a-10, A.a-39,.A.b-16, A.d-6, B.c-20, B.c-22).
Response: We agree with this comment insofar as ALARA is conscientiously
applied. However, it is not possible to insure that a largely voluntary
process will be universally or uniformly applied. To the extent that
'generic ALARA findings are possible, the establishment of administrative
control levels would correct this deficiency. See the responses to
comments 3.6.1, 3.6.8, and 3.6.9.
3.6.12 Recommendation 6 is unnecessary (A.a-41, B.a-8, B.a-14, B.a-26,
B.b-7, E.a-2).
Response: We disagree. We believe the substance of this recommendation,
as also recommended in ICRP-26, provides an important means for
eliminating unnecessary levels of exposure that are within the maximum
dose limits. See also the response to comment 3.6.11.
3.6.13 Recommendation 6 is unnecessary as Federal agencies already have
the authority to set lower limits (E.a-6).
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Response: It is true that Federal agencies already have such power.
However, guidance promulgated by executive order provides clear direction
from the President to Federal agencies to use this means to eliminate
.unnecessary exposure. . . .
3.'6.14 . Recommendation*. 6 would vitiate any attempt at rational development
of standards (A.a-13., A.d-21).' ' .
Response: This comment is not correct. .The establishment of authorized
limits or administrative control levels is a well-established component of
radiation protection standards (see ICRP Publication 26).
3.6.15 Recommendation 6 is consistent with current policy (A.d-23, B.a-9,
E.a-5).
Response: We agree.
3.6.16 If. Recommendation 6 is-retained.it should be revised to encourage
iiiteragency cooperation and consistency in setting standards (A.b-6,
E.a-4, E.ar-6.,. E-b-2).. .;,-..'.;. -.--....
Response:' Interagency'cooperation and consistency'are only particularly
necessary for those facilities-regulated by more than one -Agency. Such
cooperation already exists with few, .if any, complications of
recordkeeping, reporting, and administrative procedures.
3.6.17 If Recommendation 6 is retained, EPA should provide guidance for
uniform implementation (A.b-5, A.b-15,. A.d-23, B.a-21, B.a-44).
Response: The details of regulatory implementation are outside the scope
of Federal guidance. However, EPA will keep informed of Federal agency
actions to implement the guidance so as to promote a coordinated and
effective Federal program of work protection. See the response to comment
3.6.17.
3.6.18 Recommendation 6 would unnecessarily complicate recordkeeping,
reporting, and administrative procedures (B.c-33).
Response: We disagree. See the responses to comments 3.6.16 and 3.6.17.
3.6.19 Replace "federal agencies should establish..." with "Federal
agencies may establish..." (E.a-4, E.a-6).
Response: The final recommendations make this change.
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3.6.20 Recommendation 6 should Be included in Section 4, and should refer
to ALARA goals rather than limits (E.b-1).
Response: We believe the establishment of radiation exposure control
measures.is important enough to warrant a separate recommendation
Therefore, the use., of. administrative control, level's is recommended in
final guidance to achieve a key .objective of the- guidance, ALARA
exposures. See-also the responses to comments 3.6.1 and 3.6.7.
3.6.21 Setting administrative levels should be the function of industry,
not federal regulations (A.a-45, A.a-8, A.d-18, A.d-42, B.a-2, B.a-32,
B.a-46, B.c-12, E.b-8).
Response: We disagree. Administrative control levels can be used by
either regulatory or industrial authorities. See also the response to
comment 3.6.3.
3.7 -. ' OCCUPATIONAL EXPOSURE' OF MINORS
3.7.1 -The recommendation that occupational exposures to individuals
younger-than eighteen should.be limited to one^tenth of the Radiation
Protection Guides for adult workers is acceptable (A.a-10, A.a-39, A.a-41,
A-.b-5, A.b-6, A.d-11, A.d-14, A.d-29, A.d-40, B.a-5, B.a-8, B.a-11,
B.a-14, B.a-26, B.a-32, B.a-33, B.a-46, B.a-48, B.a-53, B.c-12, D-2,
E.a-2, E.a-3, E.a-5, E.a-6, E.b-2, E.b-9).
Response:. No response required.
3.7.2 Adoption of this recommendation should have little or no effect on
radiation exposure in the health care and nuclear industries (A.d-18,
B.a-7, B.a-36, B.c-20). .
Response: No response required.
3.7.3 Recommendation 7 is made without justification (A.d-23, B.a-7,
B.c-20).
Response: This recommendation is implicit in previous guidance (25 FR
4402), complies with existing' Federal laws on employment of minors, and is
consistent with accepted international practice (IAEA82). Therefore, we
proposed no change and it appears in final recommendations.
3.7.4 Recommendation 7, which restricts occupational dose to those under
18 to 0.1 RPG, would result in an annual permissible dose of 50 millirem
if Recommendation 8.d is adopted (A.a-14).
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Response: Proposed alternative 8d represented an extreme solution, out of
four alternative recommendations for protection of the unborn, that was
not adopted in final recommendations.
3.7.5. Recommendation 7 should be clarified to read "...in addition to any
other "Federal .restrictions, the occupational exposure .'of individuals
younger than- eighteen years should be limited to 5.0 mSv per year."
(A.b-8)*. '"'" .-"--.. . .. -. ;
Response: The additional phrase "in addition to any other Federal
regulations" was not included in final recommendations because it is
implicit to all the recommendations. Numerical limitations in SI units
are specified in parenthesis.
3.7.6 Is it the intent of Recommendation 7 that an individual under age
18 be limited to one-tenth of the 5 rem/yr whole body RPG or one-tenth of
each range limit? (E.b-3). . . ...
Response: ' The Proposed recommendation 7 for minors explicitly refers only
to one tenth of the numerical limits (RPGs), and not the suggested ranges
;fqr-proposed .recommendation^ .4V .' ..-'.--. . ".-. - .' . ...... -.-..
3.7.7 Recommendation 7 requires .clarification in view of the Range Guides
(A.b-11). '.. .
Response: See the response to comment 3.7.6.
3.7'.8 individuals less than 18 years of age should not be allowed to work
in a radiation area under any condition. (A.d-6, B.a-53).
Response: The guidance for minors serves for controlling exposures they
might receive as a student apprentice or trainee, either in formal
educational institutions or during on-the-job training (whether or not it
entails their receiving wages). We believe that most (if not all)
"employment" of minors in tasks involving radiation exposure is of this
nature. This recommendation requires that any individual who is under age
eighteen and is in an occupational type of environment be protected as
though they were a member of the general population. See also the
response to comment 3.7.3.
3.8 EXPOSURE OF THE UNBORN
3.8.1 Alternative A, which recommends that women voluntarily limit
exposure to less than 0.5 rem during any known or suspected pregnancy,
should be adopted by EPA (A.a-6, A.a-8, A.a-10, A.a-13, A.a-34, A.a-39,
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A.a-40, A.a-41, A.b-17, A.b-20, A.b-23, A.d-11, A.d-14, A.d-19, A.d-23,
A.d-29, A.d-34, A.d-40, B.a-3, B.a-6, B.a-13, B.a-17, B.a-22, B.a-26,
B.b-1, B.c-11, B.c-12, B.c-14, B.c-20, B.c-21, D-2, E.b-1, E.b-2, E.b-3,
E.b-5, E.b-9, F-3). . ' - - "'
Response:. This alternative, was ,not adopted because it places the entire
burden of protecting the unborn on- women, -i.e-. could incur economic
penalty or loss of job security. The final recommendations specify that
the dose equivalent to'an unborn'child of a woman-voluntarily declaring
her pregnancy should be maintained ALARA and should not exceed 0.5 rem
during the entire gestation period. In addition, efforts should be made
to avoid variation above the uniform monthly exposure rate that would
satisfy this limiting value. We believe this formulation reflects both
the numerical level of protection and the acceptable voluntary elements of
proposed Alternative A.
3.8.2 Alternative B, which recommends that women able to bear children
voluntarily avoid job situations involving whole-body dose rates greater
than 0.2 rem per month and to keep total dose to the unborn to less than
0.5 rem during a known.. pregnancy, should be adopted by EPA (A.a-13,
A.a-36% A.b-S, A.b-20,. A.b-22, A.b-26, A.d-6, A.d-9, A.d-11, A.d-14,
:A.d^l9,vvA>d-?9/-A/d-40',B'a-3,.: B.a-6,. B.b-7, B-.3-12,. B.a-20, B.a-22,
' "'"'"" ""'' ' '"
Response: This alternative was not adopted because it -places the burden
of protecting the unborn entirely on women, who could incur economic
penalty or "loss of job opportunity and security. See also the responses
to comments 2.1.12, 2.13.4 and 3.8.1.
3.8.3 Alternative C, limiting'women able to bear children to job
situations involving whole-body dose rates less than 0.2 rem per month and
limiting exposure of the unborn to less than 0.5 rem during any known
pregnancy, should be adopted by EPA (A.a-2, B.a-19, B.a-31, B.a-42, E.a-3).
Response: Proposed alternative C was not adopted in final guidance
because it would unnecessarily equal employment opportunities to women
able to bear children; and the desired level of protection for the unborn
could be achieved by less restrictive means. See also the responses to
comments 2.1.12, 2.13.4 and 3.8.2.
3.8.4 Alternative D, restricting whole-body doses of both men and women
to less than 0.5 rem per six-month period, should be adopted by EPA, as it
would afford all workers equal protection from radiation exposure as well
as protect the most sensitive individual (unborn) (A.c-1, A.c-2, A.d-20,
C-4, D-ll).
Response: Proposed alternative D was not adopted because of its
unacceptable impact on necessary activities in defense, medical, and
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energy applications and because the unborn can be provided the desired
level of protection by other more acceptable means.
3.-8'.5 Alternative A.is not acceptable (A.a-12, A.a-46, A.c-1, A.c-2,
'A.cKLO, A.d-12,. A.d-20, A.d-42, B.a-8, B.a-27, B.a-33, B.c-5, B.c-11, C-4,
C"-5'r .C-6,':E*.a-2, 'E-.a-S-, 'E-Va-:6)>'.'./;Yv' "' . ' . " - ;-..
.Response:- The- final, recommendation provides an assured level of
protection to the unborn without relying on voluntary action by the
mother, other than declaring her pregnancy. See also the responses to
comments 2.1.12, 2.13.4 and 3.8.1.
3.8.6 Alternative B is not acceptable (A.a-6, A.a-12, A.a-16, A.a-41,
A.b-17, A.c-1, A.c-2, A.d-10, A.d-20, A.d-34, B.a-8, B.a-12, B.a-27,
B.c-5, C-6, C-8, C-4, E.a-3).
Response: The final recommendation achieves the desired level of
protection of the unborn without denying equal opportunity rights to or
placing the burden of protection on women. See also the response to
comment 3.8.2. ' . . .
3.8.7 -Alternative C is not acceptable (A.a-13, A.a-16, A.a-36, A.a-40,
A'.a-41, A.a-46, A.b-16, A.b-17, A.b-23, A.c-1, A.c-2, A.c-10, A.d-11,
A.d-12, A.d-14, A.d-20, A.d-22, A.d-23, A.d-29,. A.d-34, A.d-40, B.a-3,
B.a-8, B.a-17, B.a-20, B.a-22, B.a-26, B.a-27, B.a-33, B.b-2, B.c-12,
B.c-20, C-4, C-5, C-6, C-8, E.a-2, E.a-6, E.a-7, E.b-1, E.b-3, E.b-6).
Response: See the response to comment 3.8.3.
3.8.8 Alternative D is not acceptable (A.a-13, A.a-34, A.a-40, A.a-41,
A.a-46, A.b-16, A.b-17, A.b-23, A.d-9, A.d-11, A.d-12, A.d-14, A.d-22,
A.d-23, A.d-24, A.d-29, A.d-34, A.d-40, A.d-42, B.a-3, B.a-6, B.a-7,
B.a-8, B.a-17, B,a-20, B.a-22, B.a-26, B.a-27, B.a-33, B.a-42, B.b-2,
B.c-5, B.c-12, B.c-20, B.c-21, C-5, C-8, E.a-2, E.a-6, E.a-7, E.b-1,
E.b-3, E.b-6, E.b-8,).
Response: See the response to comment 3.8.4.
3.8.9- Alternative D would degrade the social benefits of radiation,
and/or increase total doses and costs (A.d-9, A.d-23, B.a-22, B.b-2,
E.a-7, E.b-8).
Response: We agree that Alternative D would lead to unacceptable impacts
that are not necessary to assuring appropriate protection for the unborn
child. See also the response to comment 3.8.4.
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3.8.10 Alternative B would be acceptable for protection of the unborn if
it were rewritten to include only pregnant women instead of all women of
child-bearing age (A.b-17).
Response: ' This change would not completely satisfy the problems discussed
in the response to comment 3.8.2. .
3.8.11 Alternatives A and B' are unacceptable since they assume that the
women are sufficiently knowledgeable to make valid judgments regarding the
welfare of themselves and any unborn child (E.a-3).
Response: The final recommendations provide that workers and their
employers be informed of current knowledge of risks to the unborn from
radiation and of the responsibility of both employers and workers to
minimize exposure of the unborn and that protection of the unborn be
achieved without economic penalty or loss of job opportunity and security
to workers. However, the recommended limit for dose to the unborn is
still only invoked when a woman voluntarily declares her pregnancy.
3.8.12 Alternative D is -a "sleeper" that establishes the annual exposure
i'iini.t.at-l.O'.-rem-.; '-It :is:: totally, unacceptable (A.a-41, A.d-40, B.a-3,
B'.a-26>. ' :
Response: See the response to comment 3.8.4.
3.8.13. Alternative D would be acceptable if the reference to male workers
were dropped (E.a-3).
Response: If the reference to male workers were dropped, Alternative D
would still be subject to the objections to Alternative C.
3..8.14 The proposed guidance on Protection of the Unborn should be
withdrawn since EPA has failed to construct a valid scientific, legal, or
policy case f6r choosing amongst the alternatives (B.a-24).
Response: In proposing four alternatives we afforded the public the
opportunity to raise the scientific, legal, and policy issues they feel
are germane to protection of the unborn. The many comments received have
been useful in that regard.
3.8.15 EPA's background report exaggerates the effects on children
exposed in utero. There is insufficient evidence to make statistically
valid conclusions on teratogenic effects of in utero exposure; including
the mental retardation studies based on In utero exposures at Hiroshima
and Nagasaki (A.c-1, A.c-2, A.b-17, A.d-20, B.c-11).
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Responser .The background report summarized the most current information
on the effects of radiation on children exposed in utero.. It was not our
intent to exaggerate, and new evidence clearly substantiates our earlier
conclusion that the risk of teratogenic damage is substantial and much
.greater than hereditary risks due to exposure of workers prior to
conception. In our background report, we. placed .considerable emphasis on
evidence of structural anomalies among.the A-bomb survivors exposed to
radiation in utero. For' example, the risk of microcephaly was estimated,
assuming a linear response, as between.5 x 10~3 and 20 x 10"^ per
rem. New studies of doses at Hiroshima (RERF83,84) now indicate neutron
doses were overestimated, so that the risk of microcephaly was very
probably closer to the higher of these two values. These studies of
structural anomalies were cited as indicative of the probable sensitivity
of the fetus to more serious effects, such as severe mental retardation.
It has now become clear that this concern was well founded. The recently
published investigation by Otake and Schull of severe mental retardation
among the A-bomb survivors irradiated in utero, 8 to 15 weeks after
conception, indicates that the dose-response function seems to be linear
and without a threshold. These authors estimate this risk, to be about 4 x
.10~3 cases per rad to,the fetus (Ot84). This is not the total impact.
Less severe mental retardation also, occurred and its excess is the topic
of a paper now being drafted (W.J. Schull, personal communication). We
note !that.:thds. work'haa. been, followed.for a number'of. years by the
'International'Commission on Radiological Protection and provides the basis
for their current recommendations for increased protection of the fetus. .
The question of the sufficiency of the evidence of teratogenic,
effects in Hiroshima A-bomb survivors is a question that can not be
answered here. We have reviewed the results available in published
studies and any rebuttal or disagreement should likewise be published so
the scientific community can evaluate all the evidence. We note, however,
that there are some animal studies that support the in utero studies on
mental retardation of children of survivors in Hiroshima. Radiation
exposure has been reported to interfere with normal neuronal development
in rats (No79) and even relatively low levels of exposure can have
detrimental effects on locomotor- and maze-learning in rats (We61, We62).
The observations are also consistent with the types of teratogenesis seen
in laboratory animals (Ru71) arid with effects seen in animals at exposure
as low as 1 rad (M178).
3.8.16 Since current managerial policy is generally to limit exposures to
60% of the RPGs, it is questionable if additional restrictions on fertile
women are necessary or desirable. Such policies would limit (on the
average) the potential exposure of a conceptus to 0.5 rem during the first
two months of pregnancy without placing additional or discriminatory
restrictions on the employment of fertile women in the radiation industry
(A.b-1).
Response: We disagree. Such a general policy assures neither the
protection of all unborn nor achievement of the desired level of dose
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limitation. An explicit recommendation is required to assure protection
of the unborn as well as rights of women to nondiscriminatory treatment in
employment.
3.8.17. NCRP'Report #53 .gives adequate guidance on exposure to the unborn
(B.a-i4V-B.a-21, ;Bva;-44, B.a-48,-Eib-2, E.b-3).
Response: '.These recommendations of' the NCRP were taken into consideration
and, in large part, adopted. See also the response to comment 3.8.37.
3.8.18 Current guidance such as NCRP 39 and Reg. Guide 8.13 appear to
provide sufficient incentive for voluntarily limiting doses during
pregnancy (A.a-16, A.a-46, B.a-4, B.a-6, B.a-32, E.a-5).
Response: The existence of NCRP recommendations and NRC Regulatory Guides
do not obviate the need to include explicit provisions for protection of
the unborn in Federal guidance.
3.8.19 Recommendations 8 (a)-(c) are unacceptable for women workers as
.they,.-.would-;.vtolate^.'f.ederally secured', rights to equal employment
opportunities while' hindering the exercize of the fundamental right pf
procreation-and placing.the burden-of a. healthy and safe environment on
the worker'. EPA must assure that regulatory agencies adopt a consistent
policy in this matter (A.c-1, A.c-2, A.d-18, B.a-36, B.c-10).
Response: We agree, and the final recommendations encompass the goals
expressed in this comment. .
3.8.20 The legal constraints preventing issuing of guidance calling for
mandatory protection of unborn children must be resolved and the federal
government should take the lead (A.d-42, B.a-10, B.a-24).
Response: We believe the final recommendations, achieve this objective.
3.8.21 EPA should postpone guidance on this issue until the Federal
regulatory agencies can agree on the regulation (A.a-19, B.c-23).
Response: Federal agencies do agree on the final recommendation.
3.8.22 Congress should resolve the equal employment opportunity issues
raised in connection with the protection of the unborn (B.a-12, B.a-38).
Response: The Congress has addressed these issues. The final
recommendations are consistent with civil rights and equal employment
opportunity laws and guidelines.
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3.8.23 Alternative C is unlawful under Title VII; if the hazard affects
the fetus through women only, the exclusion must be pregnant women only
and not all women of child-bearing age (A.a-36, A.a-40, A.b-16, A.c-1,
A.c-2, A.c-10, A.d-34, B.a-7, B.a-22, B.a-26, B.b-2, B.c-11, B.c-20,
E.a-7, E.b-3,..E,b-6). ... '
Response: " We "agree. See the response to comment .3.8.24.. .
3.8.24 The reference to "women able to bear children" is over inclusive
and discriminatory. It contains the assumption that such women are always
potentially pregnant and that women cannot control when they become
pregnant (A.c-1, A.c-2, A.c-10, A.d-20).
Response: We agree. Final recommendations provide an appropriate level
of protection to the unborn child only for a woman declaring pregnancy.
3.-8.2S- Requiring all employers to make provisions for not exposing female
workers to more than 0-. 2 rem per month could restrict employment
opportunities for women (A.a-6, A.a-16).
Re'sponse;:;. We; agree... \.-ihe. appropriate protection 'of the unborn child does
not require that occupational exposure of all women be restricted, just
those who are pregnant. See the response to comment 3.8.24.
3.8.26 These guidelines will adversely affect labor agreements,
particularly pregnant worker agreements (C-2).
Response: We disagree. The final recommendation for protection of the
unborn is written so as to protect the rights of workers and should be
supportive of labor agreements. Since 1975, the State of Michigan has
required 0.5 rem protection of women who have submitted written notice of
their pregnant condition to a licensee or registrant (MDPH75). There are
no known cases where women have incurred discrimination, economic
penalties, or loss of job opportunity and security as a result of this
regulation.
3.8.27 Even .excluding a worker from any exposure once a pregnancy is
known may not be an adequate precaution against litigation (B.a-35).
Response: The subject of litigation is outside the scope of Federal
guidance; protection of the unborn and not prevention of litigation is the
objective of guidance. However, litigation could take into account all
the relevant factors involved, including Federal guidance.
3.8.28 EPA should have adopted the legal opinion obtained by DOE and NRC
that this problem should be treated through informed consent (E.a-5,
E.a-6, E.a-7).
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.Response: These and other Federal agencies of our Interagency Working
Group concurred with the formulation of the final recommendation.
3". 8V29 ; Protection of future generations must be given precedence over
equal job .opportunity (A.a-2,. A.b-20, B.a.-42,. D-3).
Response: Final guidance assures achievement of both objectives.
3.8.30 The mother should have the informed responsibility for protecting
her unborn child from the risk of radiation exposure (A.a-6, A.a-14,
A.a-46, A.b-1, A.d-5, A.d-23, B.a-3, E.a-7).
Response: We agree. Final guidance requires that workers (both male and
female) be informed of current knowledge of risks to the unborn from
radiation and of their responsibility to minimize exposure of the unborn.
The final recommendation recognizes the responsibility of women to declare
their pregnancies. . '
3.8.31 EPA should adopt the standard neces'sary to protect the future
, children. _ofworkers; .of ..either .sex..:-. It/should express the same level of
' concern.'£6r the health and employment rights of both men and women (A.c-1,
A."c-2, A.cr-8,. A.c-10,- B.a-53, C-4, D-5).
Response-: We believe the recpmmendations satisfy this objective. See the
responses to.comments 3.8.15 and 3.8.51.
3.8-32 Both male and female workers should receive instruction on the
potential for genetic and somatic damage from'radiation. Both males and
females wishing to parent children should be allowed, to remove themselves
from exposure situations prior to conception and during pregnancy with
provisions to retain seniority, payrate, and other benefits (A.c-1, A.c-2,
A.c-6, A.c-10, A.d-20, C-4).
Response: Final guidance includes provisions for instruction for all
workers. The proposal that both male and female workers wishing to parent
children have the option to remove themselves prior to conception was not
adopted because the risks are very significantly smaller than those to the
unborn after conception. Protection of the unborn during a declared
pregnancy is provided for. See the response to comment 3.8.31.
3.8.33 Exposure to the fetus should be restricted by ALARA procedures
during any verified pregnancy with a limiting value of 0.5 rem during the
entire pregnancy (A.a-16, B.a-7, B.a-34, B.a-48, C-8, E.a-2).
Response: The final recommendations contain these provisions.
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3.8.34 EPA should establish a mandatory exposure limit to the fetus
(A.b-13, A.d-37, B.a-33, B.a-46).
Response: The final recommendations provide for a limiting dose of 0.5
rem to the unborn.
3.8.35 .An alternative approach would be; to include the fetus., with
appropriate weigntingr in the list of critical organs (A.a-37, B.a-17,
E.a-6).
Response: This approach would require establishing a weight greater than
one (approximately 10) to achieve equivalent protection. This would be
inconsistent with the logic under which weighting factors are developed,
currently.
3.8.36 EPA should establish a mandatory exposure limit for females
(B.a-27, B.a-38). ' .
Response : This is neither needed nor desirable for either protection of
the- unborn or differential protection, between males and females. While
thete/.arev some\differences'-.in radiosensitivity between males and females,
for radiation protection purposes the relevant differences do not warrant
establishing separate sets of dose limits at this time. See also the
responses to comments 2.13.6 and 3.3.6.9.
3.8.37 EPA should adopt the ICRP's recommendation of a dose limit of 1.5
rems during any known pregnancy (A.a-37, B.a-53, E;a-6).
Response: The comment does not accurately reflect the ICRP recommendation
which assumes that, under normal practice,, the use of working condition B
will result in achievement of the recommended dose limit of 0.5 rem. The
ICRP also recommends measures to assure a uniform rate of exposure.
3.8.38 There should be a mandatory limit of 0.5 rem during pregnancy, and
a mandatory requirement 'for the employer to arrange the work situation so
there is no penalty to the employee for carrying out the protection of the
fetus (A.a-16, A.d-24, A.d-38, B.a-5, Ba.-ll, B.a-42, E.b-8).
Response: These features are explicit in the final recommendation for
protection of the unborn. .
3.8.39 Any woman suspected or determined to be pregnant should be
immediately removed from all radiation exposure for the balance of her
pregnancy without loss of job security or economic penalty (A.a-43, A.c-4,
A.c-6, C-5, C-6, C-8).
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Response: We disagree in part with this comment-. A woman who suspects or
believes she is pregnant should have to voluntarily so declare to trigger
appropriate protection of the unborn to less than 0.5 rem. Otherwise,
abuse of women's employment security could occur on the basis of false
concern for liability by an employer. Removal of the woman- from all
further, radiation exposure may. or may not be. appropriate, depending on the
level ofj exposure, and the. availability of alternative work assignments.
In; any "case,.-the exposure should-be-ALARA and assure the limit for the
unborn. ..-.. - .^ .- .
3.8.40 EPA should adopt the State of Michigan's approach to the
protection of the unborn (B.c-5).
Response: Although designed to achieve equivalent levels of protection,
the final recommendations differ from the State of Michigan formulation
(MDPH75). Final recommendations limit the unborn of a woman declaring
pregnancy to a maximum dose of 0.5 rem whereas the State of Michigan
approach limits the mother to a maximum dose of 0.5 rem after the mother
has given written notice of her pregnant condition. In addition, Federal
guidance-require-s efforts .be made to-avpid substantial variations above
the uniform^monthly exposure rate that would satisfy the limiting value.
;.Thi's..-.is:.-an Impprta-nt- feature -for .avoiding the. entire 0.5 rem being
received In the relatively short period of greatest sensitivity.
3.8.41 Protection of the unborn would be achieved if all workers under
age 35 are restricted to 0.4 rem per month, and if employers are required
to badge all such workers and report doses before they could reasonably be
expected to accumulate another 0.2 rem (A.a-46).,
Response: In our opinion the adoption of such a recommendation would be
unduly and unnecessarily restrictive when applied to all workers.
3.8.42 A female worker should not receive more than 0.5 rem in a six
month period, and once her pregnancy is known, she should be treated as .a
burned-out worker until the baby is born (C-7).
Response: Such extreme measures may not be necessary if the desired level
of protection can be provided by other means.
3.8.43 The RPG for fertile women should be 0.625 rem per three month
period (C-8).
Response: We disagree. There is no scientific or other need to so
restrict fertile women in order to protect the unborn child, if adequate
measures are taken to restrict doses once conception occurs. In addition,
this recommendation does not provide an adequate level of protection
following conception. See also the responses to comments 3.8.19 and
3.8.42.
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3.8.44 Since changing from a high-exposure to a low-exposure job is"often
unfeasible for workers in hospitals and clinics, standards applying to
both male and female workers of child-bearing age should be set (A.d-8).
Response: We believe that the final recommendations are practical, and
provide the desired level of protection for the unborn without unnecessary
dose: limitations -on iall/work'ers of parenting age. . \"
3.8.45 The guidance should simply be: "Pregnant females are limited to
0.5 rem for the year of the pregnancy." (A.a-41).
Response: The recommendations achieve this level of protection, while
also requiring that discrimination in employment be avoided.
3.8.46 If doses are limited to 0.3 rem per month for all workers, no
additional reductions on exposure of fertile women are necessary, and the
only additional requirement would be to educate such employees to report
possible pregnancies to their supervisors (A.b-1).
Response: In our opinion.such a limiting dose applied to all workers
would-Tse. .unnecesTsai:il.y restrictive,:.and appropriate protection is afforded
to the unborn by the final recommendation.
3.8.47 Exposure to the unborn should be'limited to one-tenth of the RPGs
for adult workers, with special consideration of ALARA practices for women
(A.b-8).
Response: .We believe that final guidance accomplishes the intent of this
comment.-
3.8.48 The use of sterile workers in high-dose jobs would reduce genetic
exposures (A.a-5).
Response: Yes, but we believe that such a requirement is both
discriminatory and unnecessary.
3.8.49 Women of child-bearing age should be excluded from high exposure
jobs (B.a-31).
Response: We disagree. Such exclusion is discriminatory and
unnecessary. Not all women of child-bearing age are pregnant all of the
time. Instruction on radiation risks to the unborn to all workers and
their employers, limitation of the unborn to 0.5 rem when their mother
declares pregnancy, and application.of ALARA will provide adequate
protection of the unborn.
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3.8'.50 The proposed NRC amendments to 10 CFR Parts 19 and 20 dealing
with the,unborn should be adopted in place of EPA's proposed guidance
(B.c-12).
Response: The draft NRC amendments which .were based on informed consent,
.would .not. provide.assurance of protection of the unborn, and would subject
women to potential economic;'penalty. ' -
3.8.51 EPA has considered risks of teratogenic effects to liveborn, but
has underestimated, particularly from exposure of males, the risks of
genetic effects, including those that do not result in liveborn. This
leads to inadequate protection of the unborn and to sex discrimination
(A.a-5, A.c-1, A.c-2, A.c-10, A.d-20).
Response: Doses to the unborn give rise to teratogenic effects and occur
as a consequence of exposure of the expectant mother, while doses to the
gonads. of male or female workers give rise to genetic (hereditary) risks,
which affect the children, of such workers.
. -Two issues need to be examined: first, the relative risks from
irradiation of male vs..female prospective parents; .and second, the size
'of'- these hereditary risks, compared to the risks from, direct irradiation of
the' fetus. ;....
The 1980 National Academy of Sciences BEIR-III report (NAS80,
pages-85 and 127) indicates that the risk to a child.is between 4 x 10~6
and 61 x 10~6 per rad to the male gamete and because of lower
sensitivity of the oocyte between 1 x 10"~6 and 14 x 10~6 per rad to
the female gamete [these values are somewhat smaller than those cited in
.our Background Report (EPA81),. which was. based on the earlier BEIR-I
report (NAS7.2)]. Recently, our Science Advisory Board's Subcommittee on
Radionuclides informed us that they believe recent studies by Dobson, et.
al. (Doa83, Dob84), indicate that the BEIR-III Committee's assumption that
oocytes are about 5 times less prone to genetic damage than spermatogonium
may not be valid. The Subcommittee advised the Agency'to use hereditary
risk estimates that assume equal male and female sensitivity, i.e.,
hereditary risks per child of between '4 x 10~6 and 61 x 10~6 per fad
to the gamete of either parent (EPA84c). Our staff believes that the
Subcommittee may be correct, but, since the question is as yet unsettled,
consideration of both ranges for females is appropriate in estimating
hereditary risk.
It should be noted that these estimates of hereditary risks are
based on animal studies. Excess genetic effects have not been substan-
tiated in studies of the children of A-bomb survivors or in other studies
of human populations; at most, the data are suggestive. And, although
peer-reviewed quantitative estimates of the risk of severe mental retar-
dation are, as yet, based on a single study (Ot84), the observed excess of
this effect in humans as a result of fetal exposure is clear-cut. The
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risk of severe mental retardation is 4 x 10~3 per rad or 2-3 orders of
magnitude greater than genetic risk on a unit dose basis.
" In' comparing the risks from in utero exposure to hereditary
risks, it should be no-ted that the relative importance of each depends on
the. duration and pattern,of exposure. .Most of the .in. utero risk seems to
result - from exposure during, a-very, short-period, from. 8 to 15-weeks after
conception. Risk of genetic damage, on the other hand, accumulates
throughout the"period' of exposure. 'Therefore, the relative importance of
each depends on to what extent male or female workers have been exposed
before their children are conceived. Nevertheless, the in 'utero risks are
very high, and since the estimated hereditary risks cited above are two to
three orders of magnitude less per rad of exposure, even an exceptionally
long term or high level of exposure prior to conception should not elevate
hereditary risks to a comparable level.
Commenters have cited the following publications, among others,
in support of increased sensitivity of males to contribute to adverse
outcomes of pregnancy and to pass genetic effects on to future
generations: L.K. Wagner and' L.A.. Hayman (Waa82), J.A. Bonnell and G.
Harte (Boc78), J.F. Crow (Cr55), S.H. Macht and P.S. Lawrence (Ma55), and
J. Boue, A.. Boue and-P.» Lazar (Bod76).- The Bonnell/Harte paper and the
Wagner/Hayman paper-'.'discuss..point's of .radiation protection philosophy and
"do not' present data or discuss'the question of maternal versus paternal
.contributions to', genetic- effects.-
The paper by. Crow addresses only the absence of a difference in
fetal and infant death rates in progeny of male radiologists vis-a-vis
male pathologists. However, the number of subjects was small, no exposure
data is available and there is no comparison group of female
radiologists.. The Macht/Lawrence paper also addresses only small numbers
of male radiologists with unknown exposures and concludes there is
.increased probability of congenital defects associated with radiation
exposure. These papers shed no light on the question of differences of
such effects in maternal versus paternal exposure to radiation.
. The Boue et_ a_l_., paper concludes that in a comparison of cases of
maternal and paternal exposure [of unknown magnitude] there is a
significant increase in chromosome anomalies in cells obtained from
spontaneous abortion tissues when the father was exposed to radiation in
the occupational setting. However, the increase is all in the incidence
of triploidy and tetraploidy. It has been estimated that 21% of cases of
triploidy are due to. maternal nondisjunction, 49% are due to dispermy and
30% due to dispermy or paternal nondisjunction with dispermy being more
probable; while tetraploidy is due to failure of a cleavage division in
the zygote (JabSO). Only nondisjunction is reported to be radiation
related. Dispermy (fertilization of an egg by two sperm) is not
considered a genetic effect but a problem of fertilization. Cleavage
failure in the zygote is also not a genetic effect related to radiation
exposure of the parental gametes. Therefore, the differences observed by
Boue e_t_ al. appear unlikely to be related to differences in maternal
versus paternal exposure.
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Consequently, we conclude that for reproductive effects, for com-
parable exposures, the risk from irradiation of the unborn is substantially
greater than the risk from irradiation of either parent or both prior to
conception.' Thus, control of.dose, to the unborn is the primary considera-
tion for minimizing such effects, not control of dose to parents. We
believe that the-..recpmmenda.tlons-for worker exposure,, designed primarily
to -'protect against cancer in'workers;-are. also sufficiently protective of
genetic risks. It is perhaps worthy of note that, although the risk of
cancer 'fatalities is somewhat1 larger 'for female than for male workers
because of the greater radiation sensitivity of breast tissue, the
recommendations call for the same limit for protection of male and female
workers. In part, this is due to our desire to avoid discrimination in
employment. See also the responses to comment 2.13.6 and 3.3.6.9.
3.8.52 EPA has underestimated the effect of radiation on the unborn
(A.c-4, A.c-6, D-3).
Response: We do not believe-that we have underestimated these effects, on
the basis of the most current available scientific information. See the
.responses to comments 3.8.15- and 3.8.51.
3.8.53 .EPA should place the risk of radiation exposure to the unborn in
perspective by comparing it with other risks taken during pregnancy.
Limiting .exposure of the mother once the pregnancy is known is the most
reasonable approach (B.a-16).
Response: We do not agree that other types of risks during pregnancy are
relevant to limitation of risks due to radiation. However, we agree that
limitation of dose to the unborn only after pregnancy is known is the most
reasonable approach.
3.8.54 EPA has not presented adequate information on the number of women
of child-bearing age in the work-force, the possibility of their becoming
.pregnant, and the doses they now receive. Thus, the size of the problem
is unknown (A.d-22).
Response: Contrary to the comment, EPA cited in the proposed guidance, as
part of previous actions noted, its analyses of the estimated mean annual
dose equivalent and collective dose equivalent to workers in the United
States in 1975 by occupation, age and sex (CobSO). These same analyses
were updated recently for 1980 (Ku84). The latter study shows collective
dose equivalents of 29,438 and 29,913 person-terns to 436,231 and 568,121
women from age 18 to 49 corresponding to average mean dose equivalents of
67 and 53 mrem in 1975 and 1980, respectively.
3.8.55 EPA has ignored the fact that 0.5 rem refers to fetal, not
maternal dose equivalent. Thus none of the alternatives are reasonable
(A.d-12, A.d-15).
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Response: The proposed alternatives were explicit regarding the
distinction between dose to the whole body of the woman and dose to the
unborn. The limiting dose of 0.5 rem .in final recommendations refers to
unborn. ' .
3.S.-56 EPA .should, resolve the-scientific uncertainty regarding the risk
of radiation exposure to the unborn. If restrictions are scientifically
warranted, they must'be made'-mandatory (B.a-Z4).
Response: There is admittedly scientific uncertainty in this matter.
However, EPA cannot resolve scientific uncertainty in the absence of new
information. Current knowledge and recommendations of radiation
protection organizations, however, lead us to conclude that it is
necessary to include radiation protection provisions for the unborn.
Those provisions are under continuing review by EPA. Should new
information warrant making future changes, we will do so promptly.
3..S.57 EPA should.make it abundantly clear, to the public that
intra-uterine exposures within' the.-0.5. rem per-pregnancy limit are safe
(B.a-42). ; .,....,..'
.Response:' Although, the risks are believed to be acceptably small for
doses to-the unborn within a 0.5 rem limit, no one can state that such
exposures are "safe" (i.e., zero) for that limiting dose, or for any of
the limiting dose's in Federal guidance. We assume- that there is no
completely risk-free level of radiation exposure. See also the responses
to comments 1.6.11, 2.1.11, 2.2.11, 3.1.15, and 3.4.3.10.
3.8.58 None of the four alternative recommendations should be included in
the guidance; such implementing choices should be left.to the regulatory.
agencies (E.a-4).
Response: We disagree. The alternatives involve basic differences- in
radiation protection policy that it is the function of Federal guidance to
resolve. However, specific implementation is left to the regulatory
agencies, within the numerical limitation and objectives specified.
3.8.59 The proposed recommendations do not adequately provide for
employee education so that workers can make informed decisions about their
employment and radiation exposure. In particular, female workers should
be fully informed of the risks to the unborn from radiation exposure
(A.a-14, A.a-16, A.b-8, A.b-15, A,c-l, A.d-20, A.d-21, B.a-5, C-7, C-8,
E.a-2)
Response: We disagree. Proposed and final recommendations make it clear
that workers should be informed of the levels of risk -from radiation in
relation to protection of the unborn.
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3.8.60 EPA should be aware that informing workers of the risks associated
with radiation exposure of the unborn increases their apprehensions
(A.d-36). .
Response-: To the contrary, we believe that proper instruction on the
risks and on.these recommendations, for protecton of the .unborn will dispel
unwarranted apprehensions." ' . . ... .
3.8.61 If workers quit their jobs because of the risk of continuing
exposure, do worker's compensation and unemployment benefits apply
(A.d-8)?
Response: These matters are not within the scope of Federal radiation
protection guidance for occupational exposure.
3.8.62 Worker's compensation benefits should cover genetic damage of
offspring, miscarriages, and early retirement due to chronic illness for
any worker receiving more, than 0.5 rem/yr (A.c-6).
Response: '.The applicability of workerfs compensation benefits-to these
..situations; are-.' outside -the;, scope of 'Federal, guidance.
3.8.63 Radiation workers should be monitored by independent researchers
for miscarriage, genetic defects, and heart disease, and the observed
effects assigned a probability of being job related (A.c-6).
Response: Such studies have been made and are ongoing. The results of
such studies have been considered in this rulemaking and will be
considered in future rulemakings. However, such monitoring is outside the
scope of the subject Federal guidance.
3.9 EXCEEDING THE RPGs
3.9.1 We have no objection to Recommendation 9 (A.a-10, A.a-39, A.b-5,
A.b-6, B.a-5, B.a-9, B.a-26).
Response: No comment necessary. [Note: Recommendation 10 in the final
recommendations corresponds to proposed Recommendation 9.]
3.9.2 Since the proposed RPGs set limits substantially below the level of
observable effects, Recommendation 9 is a good one (A.d-11, A.d-14,
A.d-29, A.d-40).
Response: No response required.
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3.9.3 EPA should adopt ICRP's guidance (ICRP-26, Paragraph 113) for
exposures exceeding the limits of the RPGs (A.a-13, A.d-18, B.a-6, B.a-10,
B.a-14, B.a-20., B.a-24, B.a-27, B.a-29, B.a-31, B.a-32, B.a-33, B.a-36,
B.a-38, B.a-46,. B.a-48, B.a-53').
Response: Final guidance does not adopt the dose limits in ICRP-26
(Paragraph' 113) "for "planned special exposures*" -This matter is left up
to the Federal agencies because they have the.detailed- information
'required to make judgment's oh-'these'matters, and we "do not believe that
generic provisions for such situations are appropriate.
3'. 9.4 Recommendation 9 should be deleted. Allowing "planned special
exposures" will only allow the guidelines for worker protection to be
ignored (A.a-5, A.c-4, A.d-8, C-l, C-6, E.b-3).
Response: We disagree. Proposed recommendation 9 is effectively the same
as recommendation 7 of current guidance (25 F.R. 4402) which states: "The
.Guides may be exceeded only after the Federal agency having jurisdiction
has carefully considered the reason for doing so in light of the recommen-
dations, in this, paper.". To our knowledge, that recommendation has not been
abused. To date, we know of no use of this provision by the Federal agen-
cies^ 'vo'the'r'. than .the special 'guides established .by NASA, for the protection
of'astronauts-.from cosmic radiation exposures received on flight missions
(NAS70).' The basic guides-are applicable to normal operations. It is
appropriate to recognize that unusual circumstances can and do arise.
3.9.5 The restrictive wording of Recommendation 9 would deny management
the flexibility needed to deal with unforeseeable circumstances (A.d-18,
B.a-3, B.a-29, B.c-20).
Response: We disagree. Recommendation 9 may have been mistakenly thought
applicable to emergency exposures, contrary to Note 5. This provision is
clarified in the final recommendations (Recommendation 10) and we believe
it's scope and intent is amply clear to the regulatory Federal agencies to
which the guidance is directed. Management at the user level will be
guided by corresponding regulations and regulatory guides of the Federal
agencies.
3.9.6 Allowing each regulatory authority to decide if, and by how much,
the 5 rem/yr limit may be exceeded will lead to confusion and
inconsistency (D-6).
Response: We very much doubt that such will occur because it has not
occurred in the past under similar Federal guidance. See the responses to
comments 3.9.3, 3.9.4, and 3.9.5.
3.9.7 The requirement for prior regulatory approval could result in admin-
istrative burdens and costly delays (B.a-3, B.a-6, B.a-32, B.a-37, B.a-48).
154
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Response: The only previous approval for exceeding numerical limitations
was given by NASA (NAS70) and administrative burdens, and costly delays
were not an issue. See also the response to comment 3.9.4.
3.. 9.8- .The; requirement, for prior regulatory approval could jeopardize
safety .('A.d-18,B."a-i5, B'.'a-29,;-B^a-36, BVc-20, E.a-6)..
Response: We-' disjagre'e. Short of' emergencies that are excepted by this
recommendation, there is no reason for prior approval to jeopardize
safety. .
3.9.9 EPA should provide criteria and standards for justifying planned
special exposures (B.a-33, B.a-38).
Response: The regulatory Federal agencies have the best understanding of
actual needs in activities under their jurisdiction. Hence, for unusual
circumstances, they are. better able to. establish appropriate regulatory
requirements for radiation protection.
'.3.i.9r,LO V Unless-- the .-intent : is" to 'gut.. the RPG: limits, exceptional
circumstances and maximum acceptable upper limits must be better defined
'
Response: Past radiation practice provides no evidence for. such an
apprehension. See the responses to comments 3.9.4 and 3.9.9.
3.9.11 The requirement for mandated Federal, review should be dropped
(A.d-23, B.a-8, B.a-12,'B.a-14, B.a-27, B.a-31, B.c-12, B.c-22, D-2).
Response: We believe that review and authorization by Federal agencies to
exceed numerical limitations, except during emergencies, is a responsible
requirement that assures due consideration of unusual circumstances. See
the responses to comments 3.9.^4, 3.9.7, 3.9.8, and 3.9.9.
3.9.12 The rationale for public disclosure is unclear.' It will not help
protect workers. It should be deleted (A.a-41, A.d-40, B.a-8, B.a-16,
B.a-22, E.a-5).
Response: Public disclosure will provide public notice that an authorized
use .of final recommendation 10 was carefully considered to assure that
workers are responsibly protected.
3.9.13 The burden for public disclosure must rest with the employer, not
the licensing agent (A.d-6).
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Response: An employer may also provide public disclosure, but Federal
agencies acting on behalf of the public should make such authorizations a
matter of public record. See the responses to comments 3.9.4 and 3.9.12.
.1,9.14 EEA should state that Recommendation 9 does not apply in
emerge-ncy'/lifesaving-situations- (E.a-*5-)'. '. "
Response: This.-wa's'the intent" of'Note. 4 of the proposed recommendations.
'However, Recommendation 10 (replaces proposed Recommendation 9) of the
final recommendations explicitly exempts "emergencies," which would
include lifesaving situations.
3.9.15 Recommendation 9 should be rewritten to include emergency
situations (B.a-48, B.a-27, B.c-22).
Response: We disagree. Emergency situations are unpredictable and cannot
by their nature be regulated. .However, the. handling of emergency
exposures should involve the general principles of this guidance. See the
response to comment 3.9.14. .....
* :.'' ''.'. 5''.'''.t::"-':;-- .:'.-' '.' :''-:-'" \'' ' .-.':.- .-:.1'. ..,'--.- .''.-''.' .-.,-'. . . .'. .
3.9.16 The workers -receiving the higher dose must be fully informed and
voluntarily.accept the risk prior to the exposure (A.d-29, B.a-33, C-l,
E.a-4, E.a-6).
Response: Final recommendations require that occupationally exposed
individuals be instructed on the basic risks to health from ionizing
radiation. The degree and type of instruction tha£ is appropriate will
depend on the potential radiation exposures involved for their work
situations, including those of an emergency nature where the worker
knowingly and voluntarily accepts the risk.
3.9.17 The guidance to licensees should include: (1) Demonstration- that
exceeding the individual limits results in the lowest practicable level of
total person-rems for the activity; (2) the affected workers have had the
potential risks explained, and that they are understood; and (3) the
workers voluntarily accept the risk .(B.a-33).'
Response: The details of instructions to licensees are the responsibility
of regulatory agencies which implement the Federal guidance. However, the
response to comment 3.9.16 applies to the last two points of this
comment. We cannot comment on how the regulatory agencies might implement
the first point. In emergency situations, it would appear generally true
that the fewer the number of emergency-workers the lower the collective
dose to achieve the specified goal. This would be the case where there is
high "unproductive" dose received during the periods of entry, tooling-up,
and exit. However, very large individual doses would not necessarily be
acceptable just to reduce collective dose. See also the response to
comment 2.7.4.
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3.9.18 If the old guidelines (3 reins per quarter, 12 rams per year) were
retained, there would be no need for higher exposures (3.a-ll).
Response: We-disagree that .retention of the previous guides would obviate
the 'need for proposed recommendation 9, which is effectively the same as
recommendation-. 7 'of current guidance (25 F.R. 4402). Radiation exposure
in 'ather-than-normal situations (including "emergencies) would likely take
place during, periods-of less than one-quarter year. Thus, it is not clear
how'either-the c'urrent guide of' 3 rems per'quarter, or, for. that matter,
the final guide of 5 rems per year eliminate the need to provide for
unusual circumstances.
3.9.19 If the prior approval requirement is retained, it must allow
approval on a generic basis (E.a-6).
Response: Final recommendations require Federal agencies to make public
any generic procedures that specify conditions under which such exposures
may occur. ' . . . . . .
3.9.20' The need for exposures exceeding the limits should be judged by
the'.practicing.,healt.h physicist^- not- the EPA (A.a.-41)..
Response:-' EPA is not a regulatory agency of occupational radiation
exposure. Regulatory Federal agencies provide the generic criteria and
procedures governing these situations.
3.9.21 Proposed recommendation 9 should only be allowed if no individual
is subjected to lifetime doses in excess of the cumulative RPG established
in'the guidance (E.a-4). .
Response: The lifetime accumulated dose of 100 rems in proposed
recommendation 4 does not appear in final recommendations. However,
lifetime accumulated dose should be one factor, among others, in
considering workers for tasks requiring established limits to be
exceeded. See also the"response to comment 3.9.16.
3.9.22 It may be necessary to justify a higher limit for an entire class
of workers (D-2).
Response: We are aware of only one class of workers (astronauts) for
which such justification was previously established. However, such
justification by the regulatory agency having jurisdiction is provided for
in the previous, proposed and final recommendations.
3.9.23 Add the following to the section on "other considerations": "For
astronaut exposures in space, NASA will be the controlling Federal agency"
(E.a-1).
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Response: We believe it is obvious that NASA is the Federal agency having
that responsibility. In addition, we know of no group of occupationally
exposed workers for which there is not a controlling regulatory authority.
3.9v24 EPA should .emphasize that ALARA is expected to be applied in
emergency situations, and that regulatory agencies will consider to what
extent. ALARA was applied- in assessing what actions to take if the RPGs are
exceeded (A.a-8). '.''
Response: We agree that ALARA should be applied in all situations,
including emergencies. However, emergencies are exempted from proposed
recommendation 9 and final recommendation 10. Regarding unusual
circumstances, the wording of final recommendation 10 explicitly requires
careful consideration of the reasons for exceeding the numerical limits by
the Federal agency having jurisdiction.
158
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EPA84b Environmental Protection Agency, 1984, "The Radioactivity
Concentration Guides: A New Calculation of Derived Limits for the
1960 Radiation Protection Guides Reflecting Updated Models for
. Dosimetry and Biological Transport," Federal Guidance Report No.
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EPA84c . Environmental Protection Agency, 1984,. "RadionuclidesResponse
'..'.' .'-'X '-\.V>. to <; Comments;-for..^.Final Rules, Volume II," EPA 520/1-84-023-2,
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Ha75 Halford R.M., 1975, "The Relation between Juvenile Cancer.and
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IAEA82 International Atomic Energy Agency, 1982, "Basic Safety Standards
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ICRP64 International Commission on Radiological Protection, 1964, "The
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ICRP75 International Commission on Radiological Protection, 1975,
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"Statement and Recommendations of the 1980 Brighton Meeting of
the ICRP," ICRP Publication 30, Part 2, Pergamon Press, New York.
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Abnormalities, in Spontaneous Abortion," pp. 289-298 in Human
Embryonic and Fetal Death, I.' H. Porter and E.B. Hook, editors,
Academic Press, New York.
Kato H. and Schull W.J., 1982, "Studies of the Mortality of
A-Bomb Survivors, 7. Mortality; 1950-1978: Part I, Cancer
Mortality," Rad. Research, 901. 395-432. (Also published by the
Radiation Effect Research Foundation as: RERF TR 12-80, Life Span
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"Occupational Exposure to Ionizing Radiation in the United
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Land C.E.,. Boice J.D., Shore R.E., Norman J.E. and Tokunaga M.,
et al., 1980, "Breast Cancer Risk from Low-Dose Exposures to
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Land C.E., 1980, "Estimating Cancer Risks from Low Doses of
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Land' C.E. and Pierce D.A., 1983, "Some Statistical Considerations
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Health Physics. CONF 830101. National Technical Information
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Guidance and Requirements for Regulatory Impact Analysis (March 9,
1984)," Jack Faucett Associates, Chevy Chase, Maryland.
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Congenital Malformations Resulting from Exposure to Roentgen
Radiation," Amer. J. Roentgenol. Rad. Therapy and Nuclear Med.,
_73_: 442-466.
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Developmental Anomalies in. Mammalian Embryos by Low Doses and
. Interaction with Drugs, Stress and Genetic Factors," pp. 397-408
in "Late Biological Effects of Ionizing Radiation, Vol. II,"
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NAS70 ' National'Academy of Sciences, 1970, "Radiation Protection. Guides
. .; . and Constraints for Space Mission and Vehicle Design Studies
Involving Nuclear Systems," Washington, D.C;
NAS72 National Academy of Sciences, National Research Council, 1972,
"The Effects on Populations of Exposure to Low Levels of Ionizing
Radiation," Report of Committee, on the Biological Effects of
Ionizing Radiation," National Technical Information Service, P.B.
239 735/AS, Springfield, Virginia.
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"The Effects on Populations of Exposure to Low Levels of Ionizing
Radiation: 1980," Committee on the Biological Effects of Ionizing
.Radiation. National Academy Press,. Washington, D.C.
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:-;':':-.. :Hea.ltkj: Education and Welfare;:."United States Life Tables:
.1969-71,." !_, No.!. .
NCRP71 National Council on Radiation Protection and Measurements, 1971,
' . . "'Basic Radiation Protection Criteria," NCRP Report No.39, NCRP',
Washington, D.C.
NCRP80 National Council on Radiation Protection and Measurements, 1980,
-"Influence:of Dose-and Its Distribution in Time on Dose-Response
Relationships'-for Low-LET Radiation," NCRP Publication No. 64,
. NCRP, Washington, D.C.
No79 Norton S., 1979, "Development of Rat Telencephalic Neurons After
Prenatal X-Irradiation," J. Environ. Sci. Health, C13: 121-134.
NRC82 Nuclear Regulatory Commission, 1982, "Cost of Compliance with
Occupational Exposure Revisions to 10 CFR Part 20," Washington,
'D.C.
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Personnel Dosimetry Processing (Proposed Rule)," Federal
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165
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APPENDIX A '
COMMENTER IDENTIFICATION
-------
APPENDIX A
COMMENTER IDENTIFICATION
Page
A. Public
a. Individuals . . - A-l
b. Universities A-6
c. Public Interest Groups A-9
d. Professional/Scientific Organizations A-10
B.. Industry . .
&; '-Nuclear'Power . . . . .. « A-14
. .b..:. .Medical .. *..' ... ..' .;..-. .....'. ...... A-l 9
'. '_!,c«'.' .Otiiecs-' .'".' > r «: '«. »'' '' «. »-.« «.' >.......< A20
.C'. Unions'-' '.'/ .-. Y ".'....-... A-23 .
D. State Government . ' . . . A-24
E. Federal Government
a. Executive Agencies A-25
b.- National Laboratories A-26
F. International '. A-27
-------
APPENDIX A. COMMENTER IDENTFICATION
iomment.er Affiliation ' Commenter (Name & Address)
-Individuals ';" "; - '.'.
A.a-1 William E. Kennedy, Jr.
406 Shoreline Ct.
Richland, WA 99352
A.a-2 Stephen D. Manning
1431 W. Forest Avenue
Decatur, IL 62522
A.a3 Richard S. Bredvad
1244 North Tenth Street
Manitowoc,.-WI 54220
.A.ar4 Dr.i-. Irwih-. D^J.. .Bross . -. ..
..-.. -..- '-':'Rb:9weir Park Memorial Institute
' ' '.'. New York State Dept. of Health
666 Elm Street
Buffalo, NY 14263
A.a-5 Marvin I. Lewis
6504 Bradford Terrace
Philadelphia, PA 19149
A. a-6 Ormand L. Cordes
2201 Brandon Drive
Idaho Falls, ID 83401
A.a-7 Rosalie Bertell, Ph.D., G.N.S.H.
Jesuit Centre
947 Queen Street East
Toronto, Canada M4M 1J9
A.a-8 Gregory P. Yukas
790 West "J" Street
Benicia, CA 94510
A.a-9 Henry Hurwitz, Jr.
827 Jamaica Road
Schenectady, NY 12309
A.a-iO W.S. Geiger
741 Woodhall Drive
Lakeland, FL 33803
A-l
-------
A.a-11 Jack J. Fix, Certified Health Physicist
107 Jackson Court
Richland, WA 99352
A.a-12- Patrick T..Glennon
V ZOO Marietta Ave.
.- .--..:?-. v PassaicxNJ.. 07055 : ..... .; .-. .
A,a-:1.3 Jphn. W» Duley, . Jr. .. ,
3012. Gilmary Ave.
Las Vegas, NV 8910-2
A.a-14 Gordon A. Little
1625 Richmond St.
El Cerrito, CA
A.a-15 Jerome B. Martin
Certified Health Physicist
.144 Sherman St.
Richland, WA 99352
A.a-16 ' Francesca .B. Davis'.
... .. .: .Health 'Physicist.. .......
'".'':.!; "V.: 8 Sedgewood Court . : ' '-'
North.Augusta, SC 29841
A.a-17 John C..Courtney
Certified Health Physicist
10326 Hackberry Ct.
Baton Rouge, LA 70809
A.a-18- ' Gordon M. .Lodde-
Health Physics Consultant.
619 Mulberry Lane
Edgewood, MD 21040
A.a-19 David K. Helton
123 Worcester Road
N. Grafton, MA 01536
A.a-20 James C. Carlson, M.S.
Hackley Hospital
1700 Clinton St.
Muskegon,.MI 49443
A.a-21 Stephen A. McGuire, C.H.P.
(Occ. Rad. Protection Branch, NRG)
6813 Fairfax Road (Apt. 222)
Bethesda, MD 20014
A-2
-------
A.a-22 Dwayne R. Speer.
Health Physicist
4231 W. Hood Ave.
Kennewick, WA 99336
A.a-23 Donald Busick
;.;'.; 'Operational Health Physics
. . SLAG, 'P.O. Box 4349
.-.-.'. Stanford, .CA 94305
A.a-24 Donna Earley
Radiation Safety Officer
Cedars-Sinai Medical Center
Box 48750
Los Angeles, CA 90048
A.a-25 Marilyn Wexler
Medical Physicist
Cedars-Sinai Medical Center
Box '48750
.Los Angeles, CA 9-0048
A.a.-26.. Robert .P... Plott . ; .' ' .
---:'.-'*'''.'': 6342" Caste joh Drive ..''"
; LaJolla, CA 92037
A.a-27 J.B. Dittraan
10 Arborglen
Irvine, CA 92714
A.a-28 Vincent L. Gelezunas
Veterans Administration
Medical Center
5901 East Seventh St.
Longbeach, CA 90822
A.a-29 (Name not legible)
White Memorial Medical Center
1720 Brooklyn Ave.
Los Angeles, CA 90033
A.a-30 D. Stewart Farquhar
Jet Propulsion Laboratory
Calif. Inst. of Technology
4800 Oak Grove Drive
Pasadena, CA 91103
A.a-31 Anne E. Jochens
7679 S. Holland Way
Littleton, CO 80123
A-3
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A..a-32 A.F. Klascius
Jet Propulsion Laboratory
Calif.- Inst. of Technology
4800 Oak Grove Drive
Pasadena, CA 91103
A.a-33 ' - F.W~ Sanders-- .-, . ' ;''" ' , ,'..'.
Rad,'Safety Officer ' ' '
- Jet Propulsion-Laboratory ...'..;'.
' Calif. Inst. of Technology
4800 Oak Grove Drive
Pasadena, CA 91103
A.a-34 J.W. Cure, III
2308 Interlink Road
Lynchburg, VA 24505
A.a-35 J.H. Heacock, CHP
1801 St. John Road, 40H
' Seal Beach, CA 90740 '
A.a-36 'Gerald'R. 'Campbell .
--...- ., 1230,.York'.Ave... Box 29. .-. -,
r;^:'N;/;-New: York,V:NY--'--; 10021;'';..',' ;:; "' ; '
A.a-37 ' James L. Blaha '.
U.S. Nuclear Regulatory Commission
"Washington,. D.C. 20555
Enclosure: Comments From
Commissioner John. F. Ahearne
A.a-38 -Edward P. Radford, M.D.
Prof, of Environmental Epidemiology
Univ. of Pittsburg, and Former
Chairman of the National Academy of Sciences
Coram. on the Bio. Effects of Low-Level
Radiation (BEIR-III)
A.a-40 Charles B. Meinhold
Brookhaven National Lab.(BNL)
Upton, NY
A.a-41 A.L. Biaetti
Certified Health Physicist
A.a-42 Robert J. Catlin
Nuclear Safety Analysis
Center (NSAC)
Palo Alto, CA
A-4
-------
A.a-43. Thomas B. Doyle (OCAW)
3842 Legde Bay Road
' 'Lumrni Island, WA 98262 .
A.a-44 Dr. & Mrs. .Neil Aronspn
-, . . ' 9822 Kar.lov . -. .. ' .
:'. :;-' ';-,, Skokie> -IL ' 60076 . -_ ; .
A. a*r45 , : Drv- Roger, doping
Radiation Safety Officer
San Jose University
A.a-46 Terry Johnson
Goddard Space Flight Center
A.a-47 George O'Bannon
A.a-48 Al Tschaeche
'A.a-49 ' Ronald G.' Blanken Baker, M.D.
State Health Commissioner
' ' ' Indiana State Board of. Health
.13.30- W. Michigan. St. ; ,'.
.', ' IN".' 46206 :'\ '"'
A.a-50 ' Ralph C. Pickard
Ass't Commissioner for Env. Health
Indiana State Board of Health1
1330 W. Michigan St.
. . Indianapolis, IN 46206
A.;a-51- 'Hal S. Stocks, Chief
Rad. Health Sec., Div. Ind. Hyg. and Rad. Health
Indiana State Board of Health
1330 W. Michigan St.
Indianapolis, IN 46206
A.a-52 Frank D. Riggs
Radiation Safety Officer
The Aerospace Corporation
P.O. Box 92957
Los Angeles, California 90009
A.a-53 Robin K. Durkee
EG&G
Energy Measurements Group
130 Robin Hill Road
Goleta, California 93017
A-5
-------
A.a-54 E.A. Manughian
Radtronics Company
3244 Arroyo Seco Avenue
, . Los.Angeles, California 90065
b.'- Individuals from Universities . :
A.b-1 Edward ;I.-Shaw '..' . ..'. ,
Professor of Radiation Biophysics
The University of Kansas
Lawrence, KS 66045
A.b-2 Bernard L. Cohen
University of Pittsburg
Dept. of Physics and Astronomy
Pittsburgh, PA 15260
A.b-3 Harald H. Rossi
College of Physicians & Surgeons
of Columbia University.
Department of Radiology
.. ..-.-'630;;West.-1.68th Street . . . .
-:'.!;/."'v";t 'New-:Ybrk^NY : 1.0032'- '>'''-..-
A.b-4 ' Reynold F." Brown, M.D.
University of California
Office of Environmental Health-" and Safety
1344 3rd Avenue
San Francisco, CA 94143
A.b-5 Anthony R. Benedetto
Division of Nuclear Medicine
Health Science Center at San Antonio
The University of Texas
7703 Floyd Curl Drive
San Antonio, TX 78284
A.b-6 George R. Holeman, Director
Health Physics Division
Yale University
314 Wright Nuclear 'Structure
Laboratory, West
260 Whitney Avenue
New Haven, CT 96520
A.b-7 John H. Tolan
Radiation Safety Officer
University of Missouri
413 Clark Hall
Columbia, MS 65201
A-6
-------
A.b-8 Roger'Ji Kloepping
University Radiation Safety Officer
'' San Jose -State University
: . Washington"Square-
San Jose, CA 95192
Aibr-9-" . Lawrence D-.-Weiss, Ph.D,
. ' .'.'Director, Occupational and
. '-" Environmental Health Program
The University of New Mexico
School of Medicine
Albuquerque, New Mexico 87131
A.b-10 - Stewart C. Bushong, Sc.D.
Professor of Radioologic Science
Baylor School of Medicine
Texas Medical Center
Houston, TX 77030
A.b-11 Gerald. A. Schlapper
Nuclear Engineering Dept.
' ' "' Texas A&M University
:..'....., .College Station, TX 7-7843. ..
A.b-12 . Ralph G.' Robinson,- M.D.
The University of Kansas-Med. Center
Dept. of Diagnostic Radiology
Kansas City, KS 66103
A.b-13 John W. Thomas
University of Pennsylvnia
Radiation Safety Committee
Philadelphia,' PA 19174
A.b-14 Suresh, K. Agarwal, Ph.D.
University of Virginia
Box 375 Medical Center
Charlottesville, VA 22908
A.b-15 Eugene L. Saenger, M.D.
RIL .- #577
University of Cincinnati Med. Center
234 Goodman St.
Cincinnati, OH 45267
A.b-16 Richard C. McCall, et al.
Health Physicists
Stanford University
Stanford Linear Accelerator Center
P.O. box 4349
Stanford, CA 94305
A-7
-------
A.b-17 Edward W. Webster, Ph.D.
Prof, of Radiology
Member, BEIR III Committee
. . Massachusetts General Hospital
Fruit Street
- . Boston, Massachusetts 02114-
.'A.b-18 ' Henry C. Briggs- '
' ' .. Radiation: Saf.ety .Of ficer
Indiana University
625 North Jordan Avenue
Bloomington, IN 47401
A.b-19 Robert M. Boyd
Radiological Safety Officer
Georgia Institute of Technology
Atlanta, GA 30332
A.b-20 John E. Doerges
Radiological Safety Control Program
The University of Wyoming.
' '. ' Lararai.e, WY' 82071
A.b-2t ;':V'jiar.y:':ff.- ''Melville' ' . V-::|;-. 'v;. .-.-';'-. -"
Research Associate .
:' Clark'University
: Center for Technology, Environment,
and Development
Worcester, MA 01610
A.b-22 Ronald E. Zelac, Ph.D., C.H.P.
Director; Radiological Health
arid Biohazards Control
Temple University
Philadelphia, PA 19140
A.b-23 Kenneth R. Kase, Ph.D.
Div. of Physics-Dep. of Rad. Therapy
Harvard Medical School
44 Binney Street
Boston, MA 02115
A.b-24 Roland A. Finston, Ph.D.
Director of Health Physics
and Hospital Radiation Safety Officer
Stanford University
67 Encina Hall
Stanford, CA 94305
A-8
-------
A.b-25 Karl Z. Morgan
School of Nuclear Engineering
Georgia Institute of Technology
Atlanta, GA 30332
A-b-26 Herman. Cember
-. . ---Professor of -Env.. Health- Engineering
: ' Northwestern'University'
. ... .. Evansto.n, IL-. 602Q1 . ,. ...
Public Interest Groups
A.c-1 Coalition for the Reproductive
Rights of Workers
1917 Eye Street, N.W. - Suite 201
Washington, B.C. 20006
A.c-2 Joan E. Bertin
American Civil Liberties Union Foundation
: '. 132 West .43. Street . '
: .'. ' New York, NY ' 10036
.A.c^J- ''.Thomas-B..: Cbchran, Ph.D. -''
. . . Natural Resources Defense
Counc i1, Inc. .
A.c-4 Kitty M. Tucker, Director
Radiation Law Project (RLP)
A.c-5 Robert Alvarez
.- " Environmental Policy Center ,
A.c-6 Catherine Quigg
Research Director
Pollution & Environmental
Problems, Inc. (PEP), Box 309
Palatine, IL
A.c-7 Robert Ginsburg, Ph.D.
Citizens for a Better Environment
A.c-8 Karen Peteros
Low Level Radiation
Committee (LLRC) *-
San Francisco, CA
A.c-9 Andy Hull
Scientists and Engineers for
Secure Energy, Inc.
2011 I Street, N.W.
Washington, D.C.
A-9
-------
A.c-10 Karen Eccles, Legal Intern
(For Donna Lanhuff, Staff" Attorney)
Women's Legal Defense Fund
'.' 2000 P.. Street, N.W.. (Suite 400)
' . Washington, D.C. 20036
..-. Professional/Scientific Organizations-
A.d-1 W.C. Reinig, President
Health Physics Society
. Savannah River Plant
Aiken, South Carolina 29898
A.d-2 Philip Handler, President
National Academy of Sciences
2101 Constitution Avenue
Washington, D.C. 20418
A.d-4 F.L. Purcell, M.D., President
American Occupation Medical Association
.. - '.-..; .'Hydra-Matic Division . . . . .
V''''"- -"-.":?'. General Motors Corporation .
Ypsilanti,.Michigan 48197
A.d-5 Colin G. Orton, President
American Association of Physicists
in Medicine
Rhode Island Hospital
Radiation Oncology Department
'. Eddy Street
Providence, Rhode Island 02902
A.d-6 Wallace W. Hinckley, Chairperson
New England Radiological Health
Committee
State of Maine
Dept. of Human Services
State House Station 11
Augusta, Maine 04333
A.d-7 Columbia Chapter
Health Physics Society
P.O. Box 564
Richland, Washington 99352
A.d-8 Karen A. O.'Rourke, RN, MS
The Federation of Nurses and
Health Professionals
11 Dupont Circle, N.W.
Washington, D.C. 20036
A-10
-------
A.d-9 J.R. Lovell, Pres. -Elect
Eastern Idaho Chapter of the
. Health Physics Society
. 455 Croft Drive-
..;. . .: Idaho Falls, Idaho 83491- .
AJd-10 James H. Saramons, M.D.
...'' .:;. Executive. Vice President . .
American- Medical Association
535 North Dearborn Street
Chicago, Illinois 60610
A.d-11 Ward M. Keller, R.T.
Executive Director
The American Society of
Radiologic Technologists
55 East Jackson Blvd.
Chicago, Illinois 60604
A.d-12 " American Association of Physicists
. ' "in Me'dicirie ''.,'' ' .
;....'- : The Midwest .'Chap tar
'' " -^- -
Illinois - 60141
A.d 13 Scientists and Engineers
' . for Secure Energy, lac.
1225 19th Street, N.W.
Suite 415
Washington, D.C. 20036
A.d-14 Otha Linton, Director of
Governmental Relations
American College of Radiology
6900 Wisconsin Avenue
Chevy Chase, Maryland 20015
A.d-15 Lincoln B. Hubbard, PhD
Health Physics Society
Midwest Chapter
1825 West Harrison Street
Chicago, Illinois 60612
A.d-16 H. Dean Belk, M.D.
President, American Occupational
Medical Association
150 North Wacker Drive
Chicago, Illinois 60606
A-ll
-------
A.d-18 Gary T. Barnes, President
The Alabama Chapter of the
Health Physics Society
University of Alabama
Dept. of Radiology - University Station
Birmingham, Alabama 35294 . '
A.d-1'9 Dr.' F« Eugene Holly, 'President ' ' '
,Am. Assoc. of Physicists .in. Medicine
Southern California Chapter
UCLA, Center for Health Sciences B3-143
Department of Oncology
Los Angeles, California 90024
A.d-20 Jeanne M. Stellman, Ph.D.
Executive Director and
Associate Professor
Women's Occupational Health Resource Center
Columbia University, School of Public Health
60 Haven Avenue, Room B-106
New. York, New York 10032
.A.d-21 ... .Dona-Id Holmquesf,. M.D. Ph..D. ..
;..-..-" .;'::;Paul-:Murphy, Ph.D. :..;';'
' Robert Anger, M.S.
American College of Nuclear Physicians
1101 Connecticut Avenue, Suite 700 .
Washington, .D.C. 20036" '
A.d-22 Warren K. Sinclair, Ph.D.
President
and
Harold 0. Wyckoff, Ph.D.
Honorary Member
National Council on Radiation
Protection and Measurements (NCRP)
A.d-23 Dr. Warren W. Schadt
Georgetown University
Washington, D.C.
A.d-24 Jean St. Germain
Sloan-Kettering Cancer Center
A.d-25 Capt. William H. Briner
Dept. of Nuclear Medicine
Duke Univ. Medical Center
A.d-27 Donald L. Holmquest, M.D.
President, Health International, Inc.
Houston, Texas
A-12
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A.d-28 Paul H. Murphy
Southwestern Chapter
Society of Nuclear Medicine
A.d-29 Dr. Lee Rogers
Chairman and-Prof. .of Radiology
':''.: .:-'' Northwestern University,; and
Chancellor of the American
... . :.. College of Radiology'(ACR) ..
A.d-30 ' Donald A. Balasa
Director, Legal Dept.
American Dental Assistants
Association (ADAA)
Chicago, Illinois
A.d-31 Larry L. Heck, President
American College of
Nuclear Physicians (ACNP)
A.d-33 .' Gerald L. DeNardo, M.D.
. University .of California
./ .Davis.Medical Center
''-:'; -'."; Sacrament 0-- California' .-. .
A.d-35 'Jerry J. Cohen
. Liyermore, California
A.d-38 Lloyd Bates, SCO
Mid-Atlantic .Chapter
American Association of Physicists
'in.Medicine
A.d-39 Ms. Wright
American Association of Physicists
in Medicine
A.d-40 Russell H. Morgan
American College of Radiology
A.d-41 Fred Sanders, President
Southern California Chapter
Health Physics Society
A.d-42 E.P. Wilkinson, President
Institute of Nuclear Power Operations
1820 Water Place
Atlanta, Georgia 30339
A-13
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B. INDUSTRY
.a. .Nuclear Power Industry
B.a-L Len Gucwa
. Chief Nuclear Engineer
;: ". ''.".;.'' Georgia. Power Company . -
B.»a-2 . -Dalwyit R^ Davidson - . ;
Vice President
System Engineering and
Construction Group
The Cleveland Electric Illuminating Co.
P.O. Box 5000
Cleveland, Ohio 44101
B.a-3 Billy R. Clements, Vice President .
Texas Utilities Generating Company
2001 Bryan Tower
' Dallas, Texas 75201'
'" B.a-4 '"jphn J. Mattimoe
-<: .-';-' Sacramento Municipal Utility District
' '"'' ": Street - Box 15830 .
' -. . ',' Sacramento, California 95813
B.a-5 Philip A.- Crane, Jr.
Pacific" Gas- and Electric Company
P.O. Box 7442
San Francisco, California 94106
B. a-6.. Morton I.: Goldman
Senior Vice President
NUS Corporation
4 Research Place
Rockville, Maryland 20850
B.a-7 Evan R. Goltra, M.D.
Kerr-McGee Corporation
Kerr-McGee Center
.Oklahoma City, Oklahoma 73125
B.a-8 Mohamed T. El-Ashry, Ph.D.
Tennessee Valley Authority
Norris, Tennessee 37828
B.a-9 Russell B. DeWitt
Vice President Nuclear Operations
Consumers Power Company
1945 Parnall Road
Jackson, Michigan 49201
A-14
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B.a-10 Richard D. Grouse
.Vice' President, Nuclear
.The Toledo Edison Company
300 Madison Avenue
-; . -Toledo, Ohio 43652
B.a-11 G. Carl' Andognini
..Vice President. .. ..
Arizona Public Service Company
P.O. Box 21666
Phoenix, Arizona 85036
B.a-12 William 0. Parker, Jr.
Duke Power Company
422 S. Church Street
Charlotte, North Carolina 28242
B.a-13 S.W. Shields
Senior Vice President
Public Service Indiana
' . " P;.0. Box 190 . .
. ..New Washington, Indiana 47162
B.a-14 R. Nilsdn, Manager
'Corp. Licensing and Compliance
Exxon Nuclear Company, Inc.
2955 George Washington Way
Richland, Washington 99352
B.a-15 R.H. Leasburg
Vice President
Virginia Electric and Power Company
B.a-16 . D.W. Zeff, Manager
Health-Safety & Licensing
Babcock & Wilcox
Mt. Athos
P.O. Box 800
Ly.nchburg, Virginia 24505
B.a-17 A.L. Cahn
Manager of Engineering
Bechtel Power Corporation
P.O. Box 3965
San Francisco, California 94119
B.a-18 D.W. Edwards, Director
Operations Project & Licensing
Yankee Atomic Electric Company
1671 Worcester Road
Framingham, Massachusetts 01701
A-15
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B.a-19 Harold L. DeHoff
Radiation Safety Officer
Newport News Industrial Corporation
230 41st Street
. ; Newport News, Virginia 23607
B.a-20 W'.G. Counsil - '" ' . d.
' . Senior Vice President ov
Northeast Utilities ' . ^
PiO. Box 270
Hartford, Connecticut 06101
B.a-21 David G. Cadena
Radiation Safety Officer
Southwest Research Institute
6220 Culebra Road
San Antonio, Texas 78284
B.a-22 G.D. Bouchey; Director
Nuclear Safety
Washington Public Power Supply System
P.O. Box 9.68 '.. . . Wt
:;:.^..;!-V;-v:Richlahdv. Washington, ;99352
' ' .
B.a-23 J.S. Loorais, Head .,
Nuclear Safeguards & Licensing Division
. Sargent & Lundy Engineers
55 East Monroe Street
Chicago, Illinois 60603
B.a-24 Joseph.Gallo
Isham, Lincoln & Beale
: 1120 Connecticut Avenue, N.W. - Suite 325
Washington, D.C. 20036
B.a-25 M.K. Sullivan
Southern California Edison Company
San Onofre Nuclear Generating Station
P.O. Box 128
San Clemente, California 926/2
B.a-26 Dick Cheney
Member of Congress
Congress of the United States
House of Representatives
Washington, D.C. 20515
Enclosed: Letter from Constituent (4 May 1981)
Ralph F. Peak
Professional Engineer
1361 Torjan Drive
Casper, Wyoming 82601
A-16
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B.a-27 J. Edward Howard
Vice President, Nuclear
Boston Edison Company
800 Boylstom Street
.Boston, Massachusetts 02199
'B.a-28 Robert- E. -Uhrig^ Vice President -
'Advanced Systems & Technology
Florida Power. & Light Company.
P.O. Box 529100
Miami, Florida 33152
B.a-29 Lester Rogers
Health Physicist
B.a-30 William D. Rowe, Ph.D.
Director, American University
Institute of Risk Analysis
and- '
- Frederick C. Williams
-: . Isharaj Lincoln-& Beale
. . 1120 Connecticut Avenue, N.W. - Suite 325
: J:^i^-'i ^Washing tSxn.j.. Dy C v^'' 200 36v/^ '.'.,; ;,;-' :'''-..- .'.''
(Enclosures: Answers by;Dr. W.D. Rowe
to questions asked him at Washington
Hearings)
' -.
B.a-31 Vincent Boyer
Chairman of the Group;* and
Sr. Vice President, Philidelphia
:. Elec trie . Company
B.a-32 Lionel Lewis
Duke Power Company
B.a-33 Andrew T, Sabo
Ted L. Erion ...
W.S. Brown
Representing Westinghouse
Electric Corporation "
B.a-34 Dr. James R. Sumpter, Mgr.
Nuclear Services Department
and
Gordon E, Williams
Houston Lighting and Power Co. (HLP)
A-17
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B.a-35 Dr. Ralph E. Lapp
Lapp, Inc.
Alexandria, Virginia
and
; ." 'William Hoey
: ...Sr.' Radiation Protection Engineer
; ..- .'".' : Boaton. Edispn .Company ... . . ..
.'.'' : Pilgrim Nuclear Power Station.
V , .'; RFD #1 Rocky Hill Road
'' Plymouth, Massachusetts 02360
B.a-36 Dr. W.M. Jackson
Corp. Health Physicist
Alabama Power Company (APC)
B.a-37 Byron Lee
Executive Vice President
and
Cordell Reed
Vice President . ..
Commonwealth Edison.Co. (CEC)
... . Chicago, Illinois'. ',
t VB^T?£;..^Robert.-&.,P.ayl.icfc'. ;;':.:'..;.-.;,'...'.;'..-'';' .;':
J'' ''.' : 'Comnionweaith Edison Co. '(CEC)..''
B.a-39 Edward Lipke
Wisconsin Electric Co. (WEP)
B.a-40 Dr. Marvin Goldman
Davis, California
B.'a-41 Dr. George I. Hutchison
Harvard School of Public Health
Boston, Massachusetts
B.a-42 Dr. Robert Brent
Jefferson Medical College
Philadelphia, Pennsylvania
B.a-44 David G. Cadena
Radiation Safety Officer
Southwest Research Institute
6220 Culebra Road
San Antonio, Texas 78284
B.a-45 William R. Hoey
Sr. Radiation Protection Engineer
Boston Edison Company
Pilgrim Nuclear Power Station
RFD #1 Rocky Hill Road
Plymouth, Massachusetts 02360
A-18
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B.a-46 J.S. Moore
General Manager
Water Reactor Divisions
Westinghouse Electric Corporation
''" Nuclear Center
,...../ '.. 'Box 355-' : ' ' ', ' . .
".: 'Pittsburgh, Pennsylvania .15230
B.a-48 William J. L. Kennedy . '
Chairman, AIF Committee on Environment
Atomic Industrial Forum, Inc.
1747 Pennsylvania Avenue, N.W. - Suite 1150
Washington, D.C. 20006
B.a-50 E. David Harvard, Envir. Project Manager
Atomic Indust. Forum, Inc.
7101 Wisconsin Avenue
Washington, D.C. 20014
B.a-52 Frederick C. Williams
Isham', Lincoln & Beale .
Utility. Occup. Rad. Stnds. Group.
.^;.^.x'}~-;., ;tl20 Cpnnec.ticu.t. A.veriue,. N..W... .'...
'."'"' Washi'hgtpri, D.'C. 20036. . " '
B.a-53 Joel I. Cehn
Pacific Gas & Electric 'Company
San Francisco, California
B.a-54 Walter D. Peeples, Jr.
President
Gulf Nuclear, Inc.
202 Medical Center Blvd.
Webster, Texas 77598
b. Medical Institutions
B.b-1 William Pavlicek, M.S.
The Cleveland Clinic, Div. of Radiology
The Clinic Center
9500 Euclid Avenue
B.b-2 C. Barrie Cook, M.D., Chairman
Radiation Safety Committee
The Fairfax Hospital
3300 Gallows Road
Falls Church, Virginia 22046
A-19
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B.b-3 Bruce J. Gerbi
Nix Hospital. X-Ray Laboratory
1502 Nix .Professional Building
. San. An-bbnio, Texas . 78205
B'.b^4.' Richard Geise, M.S.,
":' "'.';."' /'Medical Physicist'' '"'
North Memorial. Medical Center'
..-!.." 3220 flowry Avenue, .North.
Minneapolis, Minnesota 55422
B.b-5 Robert J. Flanagan, Jr., DBA
Group Vice President
American Hospital Association
840 North Lake Shore Drive
Chicago, Illinois 60611
B.b-6 W.H. Blahd, M.D., and
_ L.W. Wetterau
Radiation Safety Officer
Veterans Administration
Wilshire 'and Sawtelle Boulevards
.;.-.. / .'.',;.. -LoVAngeles,, California. 90 073-
"c. Other Industry
B.c-1 R.S. Patenaude
Proto-Power Management Corporation
591 Poquonnock Road
Groton, Connecticut 06340
B.c-2 Larry- A. Bbggs, Senior Counsel
American Mining Congress
1920 N Street, N.W. - Suite 300
Washington, D.C. 20036
B.c-3 Edwin M. Wheeler
The Fertilizer Institute
1015 - 18th Street, N.W.
Washington, D.C. 20036
B.c-4 William L. Rogers
Gulf Mineral Resources Company
1720 So. Bellaire Street
Denver, Colorado 80222
B.c-5 Paul F. Allmendinger
Vice President
Motor Vehicle Manufacturers Assoc.
of the United States, Inc.
300 New Center Building
Detroit, Michigan 48202
A-20
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B.c-6 Kenneth J. Green
Vice President
Associated Couriers, Inc.
. - 342. Fee Fee Road .
St. Louis, Missouri 63043
B.c-8 .Homer Hooks ' ". .
President ; .' . .
Florida Phosphate Council
Suite 24, Executive Plaza
4406 S. Florida Avenue
Lakeland, Florida 33803
B.c-9 C.P. Hopcraft, Vice President
Gulf Nuclear, Inc.'
202 Medical Center Blvd.
Webster, Texas 77598
(Note: Comments submitted to Docket
in' lieu of 'Oral ' Presentation at Houston
Public Hearings, 1 May 1981.).
B.c-10 Robert .G.-Wissink. . . : ....
3M Center .
St. Paul, Minnesota 55101
B.c-11 Lyda W. Hersloff, Ph.D.
Environmental Specialist
Rocky Mountain Energy
Box 2000
. Broomfield^ Colorado 80020
B.c-12 A.E. Moffitt, Jr.
Manager of Environmental Health
Bethlehem Steel Corporation
Bethlehem, Pennsylvania 18016
B.c-13 Paul B. Sunde
Vice President & General Manager
Radcal Corporation
426 W. Duarte Road
Monrovia, California 91016
B.c-14 James M. Kortright, Ph.D.
Radiation Calibration Company
P.O. Box 6432
Orange, California 92667
A-21
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B.c-16 Philip S. Rummerfield
Applied Radiation Protection Services
4901 Morena Blvd. - Suite 104
San Diego, California 92117
B..C-18 Randall W. Harman
' . V-. Radiation Safety. Officer- . '. ' . .
: ' ' Nuclepific.Data Systems, Inc.
:281.1. MeGaw. Avenue . ' .
' ' ' Irvine, California' 92714''
B.c-20 J. Allen Overton, Jr.
President
American Mining Congress
1920 N Street, N.W. - Suite 300
Washington, D.C. 20036
B.c-21 Richard N. Don.elson, CHP
6825 Bianca Avenue
Van Nuys, California 91406
B.c-22 . c'.R, Moxley . . ..'
. -Manager - Health, . Safety» &. Env,. Affairs
';./';. -'..;. 6ulfs Mineral. Resources :Company . .
1720'South Bellaire Street-
Denver, .Colorado 80222
B.c-23 C.E. Racster
Radiation Safety Officer
Schluraberger Well Services (SWS)
Houston, Texas
A-22
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C. UNIONS
C-l .-Marshall M. Hicks
.. National .Secretary-Treasurer
... Utility ."Workers- Union of America
..- '.. :815-16th: Street, N.W.- .
." . Washington,. D.'C;. 20006' ' '
C-2 :PauL Shoop '; ; . .' . .-
International Representative
International Brotherhood of
Electrical Workers
1125-15th St., N.W.
Washington., D.C. 20005
C-4 Judith Berek, Vice Pres. and
Director of Legislative and-
Professional Programs
District 1199
National Union of Hospital and
Health Care Employees (A Div.
:'. of .RWDSU/AFL-CIO) ''"
..V.'. .: 3LO:WestNA3rd Street.. .'. ... ......
'
C-5 Nolan W. Hancock, Legislative
Director
Frank Collins, Ph.D.
C-6 Lorin E. Kerr, M.D.
C-7- 'Allan Se-lby, President
Local Union 7-4200
Oil, Chemical, and Atomic Workers
International Union (OCAW)
Monsanto Chemical Co.
Miamisburg, Ohio
C-8 Tom Doyle
Local Union 1-369 . (OCAW)
Richland, Washington
A-23
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D. STATE GOVERNMENT
D-l Michael Odlang
Radiation Control Section
Dept.'of Social and Health Services
1409 Smith Tower, B17-9
;.. . Seattle-,.. WA/ 98104 . . , .... . '.
D-2; . : John, A.' Beare, M.D. , M.P.H.
'State-of Washington
Dept. of Social & Health; Services
' Olympia, Washington 98504
D-3 Antonio Hernandez, M.D., and
David Saldana
Commonwealth of Puerto Rico
Department of Health
San Juan, Puerto Rico
D-4 Karim Rimawi, P.h..D. ...
Director,.Bu. of Env. Radiation
.. . . State.of'.New..York Dept.-of Health
Albany.,' NY 122;37
D-5 "" ". Re'ittffido ;A." Ferrer,' M«D.
'City of New York., Commissioner of Health
125 Worth Street
New York, NY- 10013
D-6 Albert J. Hazle, Director
Radiation and Hazardous
Wastes Control Division
Colorado 'Dept. of Health
4210 East 'llth Street
Denver, Colorado 80220
D-10 Blaine N. Howard
Sec. Chief, Radiological Health
Utah Dept. of Health
150 West North Temple
Salt Lake City, Utah 84110
D-ll Joanne E. Finley
State Commissioner of Health
New Jersey Dept. of Health
John Fitch Plaza
Trenton, NJ 08625
A-24
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E. FEDERAL GOVERNMENT .
a. Executive Agencies.
E.a-1 Walton L. Jones, M.D.
Chief, NASA Occupational Health
.-'. .;.-..;.. National''-Aeronautics, and' Space Adnu ;
' Washington-; D.-C. 20546 ' ' . ' ' .
* * ' ' . .'»*'' '. -
E.a-2 George Marienthal
Deputy Ass't Secretary of Defense
(Energy, Environment, and Safety)
Office of the Assistant Secretary of Defense
Washington, D.C. 20301
E.a-3 Cecil S. Hoffmann
Special Assistant to
Assistant Secretary of the Interior
Office of the Secretary
U.S. Dept. of the Interior
Washington, D.C. 20240 ..
.E.aT4; :John..C,...yillforth . .;. ", ;.-.'
'v'-l.y: '-pire'etor,--Bu-." of..Radiological Health;, and
Chairman, DHHS Subcommittee to
Coordinate Radiation Activities
Public Health'Service
Food and Drug Administration
Rockville, MD 20857
E.a-5 Stephen H. Greenleigh
: Acting Deputy Assistant Secretary
for- Environment, Safety, and. Health .
Department of Energy
Washington, D.C. 20585
E.a-6 Nunzio Palladino
Chairman
U.S. Nuclear Regulatory Commission
Washington, D.C. 20555
E.a-7 David E. Patterson, Director
Operational and Environmental
Safety Division, DOE
J.'W. Healy - Los Alamos
Scientific Laboratory
Jack M. Selby - Battelle
Northwest Laboratories
A-25
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b. National Laboratories
E.b-1 John F. Sommers
EG&G- Idaho, Inc.
P.O. &ox 1625
.... -Idaho Falls, Idaho 83415.
E.b-'2''. A.G. 'Croff. "''
. .-' . . 'Chemical Technology.'Div. . . ;
Oak-Ridge National Laboratory
P.O. Box X
Oak Ridge, TN 37830
E.b-3 R.A. Wynveen, et al.
Health Physicists
Argonne National Laboratory
9700 S. Cass Ave.
Argonne, IL 60439
E.b-4 Patricia W. Durbin
Anthony Greenhouse
Charles T. Schmidt
. ; ^. V:..Ralph.. H> .Thomas;-.'; . .- ...-; .;
"'' ''".. 'Jetisen;'Young'';" ' '.".'.:'-.' ''."''":-'
Lawrence-Berkeley'Laboratory
Univ. of California
Berkeley,. CA 94720
E.b-5 H. Wade Patterson, et al.
Lawrence Livermore National LAB.
University of California
P.O.' Box 5505
. ' Livermore, CA -94550
E.b-6 Jack M. Selby, Manager
Health Physics Technology
Battelle Northwest
Laboratories (BNL)
E.b-8 Bryce L. Rich
EG&G Idaho, Inc.
P.O. Box 1625
Idaho Falls, Idaho 83415
A-26
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F. INTERNATIONAL
F-l H.T. Daw
Division of Nuclear Safety
International Atomic Energy Agency
Wagramerstrasse 5, P.O. Box 100
-.,-; _'A-1400.Vienna, Austria _
F-2. F. Morley, Secretary-and- Staff
:' ' -of Board ' . '.....
National Radiological Protection Board
Chilton, Didcot
Oxon. 0X11 ORQ
United Kingdom
F-3 R. Wilson, Director
Health and Safety Services;
Representing Ontario Hydro
D.A. Watson, Manager; and
; E. Koehl, Staff Member. . .
A-27
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