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OAR Box 1103 

Prepped by Ryan Dugan 

Document Number: 

83) ll-C-1 

Docket Number: 

A-83-41 

Printed 4/11/2008 1:50:51 PM Sheet 83 of 174 
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" • \ 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

ym-c-yL 

JUL 2.5 J994 

Eric S. Beckjord, Director 

Office of Nuclear Regulatory Research 

U.S. Nuclear Regulatory Commission 

Washington,^ DC 20555 

Dear Mr. Beckjord: 

EL'. 

Thank you for your letter of July 15, 1994, which provided . 

the Nuclear Regulatory Commission's (NRC) response to our 

November 12, 1993, request for comments on the Environmental 

Protection Agency's (EPA) draft recommendations to the President 

on Federal Radiation Protection Guidance for the General Public. 

Your letter identified four significant areas of comment: 

1) Recommendation 1 should more clearly identify the types 

of actions a Federal agency carries out to justify an activity. 

We agree, and the points raised in your comments have been 

incorporated into the text. 

2) Clarification of the circumstances under which ' 

truncation (under Recommendation 2) is appropriate is needed. We 

agree with the NRC understanding of this issue, which correctly 

reflects the original intent. The text has been amended to 

clarify this. 

3) NRC agrees with the proposed numerical value for the 

Radiation Protection Guide in Recommendation 3 (100 mrem/y), but 

additional clarification of the rationale for the choice of this 

numerical value would be desirable. We have provided additional 

clarification, including some of the suggested language. (See 

the enclosed response to comment 1.4.) 

4) Recommendation 4 could be misinterpreted to require 

prescriptive apportionment of doses to the public. We agree that 

this is not the intent, and the text has been amended to make it 

clear that it is not. (See, also, the enclosed response to 

comment II.1.) 

Based on the above resolution of NRC's significant areas of 

comment, we appreciate your support for publication of these 

proposed draft recommendations for public comment. 

TtKt CONCURRENCeS 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

JUL 2.5 J994 

Eric S. Beckjord, Director 

Office of Nuclear Regulatory Research . 

U.S. Nuclear Regulatory Commission 

Washington, DC 20555 

Dear Mr. Beckjord: 

Thank you for your letter of July 15, 1994, which provided 

the Nuclear Regulatory Commission's (NRC) response to our 

November 12, 1993, request for comments on the Environmental 

Protection Agency's (EPA) draft recommendations to the President 

on Federal Radiation Protection Guidance for the General Public. 

Your letter identified four significant areas of comment: 

1) Recommendation 1 should more clearly identify the types 

of actions a Federal agency carries out to justify an activity. 

We agree, and the points raised in your comments have been 

incorporated into the text. 

2) Clarification of the circumstances under which 

truncation (under Recommendation 2) is appropriate is needed. We 

agree with the NRC understanding of this issue, which correctly 

reflects the original intent. The text has been amended to 

clarify this. 

3) NRC agrees with the proposed numerical value for the 

Radiation Protection Guide in Recommendation 3 (100 mrem/y), but 

additional clarification of the rationale for the choice of this 

numerical value would be desirable. We have provided additional 

clarification, including some of the suggested language. (See 

the enclosed response to comment 1.4.) 

4) Recommendation 4 could be misinterpreted to require 

prescriptive apportionment of doses to the public. We agree that 

this is not the intent, and the text has been amended to make it 

clear that it is not. (See, also, the enclosed response to 

comment II.l.) 

Based on the above resolution of NRC's significant areas of 

comment, we appreciate your support for publication of these 

proposed draft recommendations for public comment. 

Ttnt CONCURRENCES 

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E f* Form 1320-1A (1/90) Printed on Recycled Paper OFFICIAL FILE COPY 

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We also considered each of your more detailed comments. We 

have made changes to address almost all of them, and I believe 

that the resulting changes will improve the clarity, 

completeness, and accuracy of the supporting text for these 

proposed recommendations. 

Enclosed is a summary of our responses to the NRC comments 

and a copy of the revised notice of Proposed Recommendations, 

Request for Written Comments, and Notice of Public Hearing, 

reflecting these responses, which we expect to publish in the 

Federal Register shortly. 

We appreciate your input, which has resulted in significant 

improvements in this proposal. 

Sincerely 

Margo T.IOge 

Director, Office of Radiation 

and Indoor Air 

Enclosures 

6602J/bc/arichardson/233-9290/7-22-94 
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Response to NRC Comments on the 

10/10/93 Draft Federal Radiation Protection Guidance 

for Exposure of the General Public 

The responses are keyed to the corresponding numbered comments in 

the NRC response. 

I. PRINCIPLES 

1) The requested additional identification of means that are 

employed to carry out justification and clarification 

regarding existing practices have been added. 

2) The possibility, in rare cases, of a need for "tradeoffs 

between larger doses to a few individuals...and many small 

doses to large populations" was not discussed further 

intentionally. There are no generally agreed upon bases 

for making such tradeoffs, and the guidance leaves these 

judgements to the implementing agencies (subject, of course, 

to any statutory constraints). 

3) We agree with the comment. Truncation is sometimes . 

appropriate and justified. The point in the original text 

was that it should not be invoked arbitrarily, but only when 

there has been a judgment made that it will not 

significantly affect the outcome of the analysis. The text 

has been clarified by language equivalent to that suggested. 

4) The requested clarification - reflecting that the point 

applies to vicinity properties - has been made. 

5) The text of the Preamble has been expanded to provide 

additional clarification of the rationale, as requested. 

The preamble also makes the suggested point that the 

proposed RPG is consistent with levels used in the 

international community. However, we have not adopted the 

suggestion that the linear non-rthreshold assumption is 

simply a conservative approach "...for consistent comparisons 

in the absence of adequate information" (emphasis added). 

It is the Agency's position that the risk estimates cited in 

the preamble represent our current best estimates of the 

hazard, not merely a consistent basis for comparison. We 

also have not adopted the suggestion that comparison with 

the risk from background radiation provides a valid basis 

for selection of the RPG, which applies to control of 

radiation exposure from man-made radiation. Although the 

risk from background radiation has been cited as a point of 

reference, to provide a perspective on the RPG, it is the 

Agency's position that risks from natural hazards do not 

provide a 'sufficient, or, in many cases, even an 

appropriate, basis for the selection of acceptable levels of 

risk from man-made hazards. 
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6) The recommendations are not intended to require 

specification of numerical limits on collective dose. 

Although Agencies could, conceivably, develop such 

requirements in some situations, the only requirement of the 

recommendations is for the optimization of dose reduction. 

That process is usually carried out through analyses of the 

collective dose. However, the conclusions of such analyses 

can be expressed as regulatory requirements for individual 

dose, total activity released, installation and use of 

specific controls, or any other specification the regulatory 

body finds appropriate. The text has been expanded the make 

this clear. 

II. IMPLEMENTATION 

1) We agree that it is neither appropriate nor practical 

normally to place the responsibility on licensees to account 

for radiation exposures of the public due to activities 

outside their control. The recommendations do not create 

such a general requirement; that responsibility normally 

rests with regulatory bodies, and, as is pointed out in the 

preamble, must necessarily be based on broad-based 

judgments. The guidance does not specify how these 

judgments should be carried out because that is, we believe, 

a matter best left to the discretion of the individual 

regulatory agencies. As noted below, the proposed guidance 

does not recommend apportionment of the RPG for this 

purpose. Finally, technical specifications are clearly one 

example of criteria that can be used to assure that the 

objectives of proposed Recommendation 4 are satisfied, and 

this example has been added to the preamble. 

Recommendation 4 is not intended to require apportionment of 

the RPG among sources; this would not be practical or even 

desirable.. The text has been expanded to make this clear. 

With respect to the regulation of individual sources, it is 

our understanding that it is NRC's intent to take into 

account the possible contributions of other sources of 

exposure in regulating individual licensees, so as to make 

it unlikely that the RPG for limiting individual dose would 

be exceeded due to the contributions of any of its 

licensees. 

2) We agree; it was. never the intent of the recommendations to 

preclude the use of conservative assumptions to demonstrate 

compliance with regulatory requirements. The statements 

regarding critical groups, and more generally, the 

exhortations for realism in calculations refer to the 

analyses carried out during the establishment of regulatory 

requirements. 

3) The requested modification of the text has been made, but 

with respect to non-occupational doses only. 
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4) Although the statement may be correct, this is a matter for 

decision between the educational institution sponsoring 

students and the research organization that accepts 

students, not for this guidance. 

III. TECHNICAL CLARIFICATIONS . 

General: Key references are included. 

1) The summlry is intended to identify only the most important 

provisions of the proposal. 

2) The requested clarification has been made. With respect to 

implementation, the only significant implication is for 

occupational exposure (female members of flight crews during 

pregnancy). That matter, which is under consideration by 

the FAA, is not the subject of these recommendations. 

3) The requested clarification has been added. 

4) The comment is correct and we will attempt to make the 

suggested correction. However, this comment was received so 

late (July, 1994) that it may not be possible to include it 

in the manuscript submitted for publication. 

5) The sentence has been clarified. 

6) We disagree. The risk estimates in BEIR V apply to low 

levels of radiation, and the level of uncertainty is 

reduced, for example, as a result of longer follow-up and 

the dose reconstruction at Hiroshima and Nagasaki, which has 

allowed the results from these two epidemiological studies 

to be combined. 

7) The text has been amended to reflect the original intent, 

which was to refer to man-made uses, of radiation. 

8) We disagree. It is EPA's view that the linear dose-effect 

relationship is the one most likely, of the various 

candidates, to represent the actual situation, and that this 

assumption is therefore not simply taken as a prudent 

position for regulatory purposes. 

9) The citation is correct; it refers to a previous note. 

10) Since the interagency group did not address this issue (at 

least not in the sense of proposing language to be included 

in the recommendations), we have responded to this concern 

by adding a question requesting public comment on the need 

for a recommendation addressing this specific issue. 

11) The text has been adjusted to address this concern. 
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12) 

13) 

14) 

15) 

16] 

17] 

18] 

19] 

20] 

21] 

22] 

• 

23] 

24] 

25] 

26] 

27] 

28! 

Although the comment is correct, it is not necessary to 

adjust the text, because the cost of analysis can be 

included in the judgment called for by Recommendation 1. 

Comment accepted. 

Comment accepted. 

The consideration of such factors is incorporated through 

the process of optimization. The factors noted (social and 

economic) are specifically identified in Note 8 accompanying 

the Recommendations. We have not incorporated these words 

into Recommendation 2 itself because it is an inadequate 

characterization of the factors that may have to be 

considered. 

The comment is correct; the text has been modified. 

The reference is to ICRP 60. See, however, the response to 

comment III.4. 

Question 7 has been added to address this matter. 

We believe that the desirability of avoiding lifetime risks 

that are greater than one in 10"3 is self evident, and does 

not require additional justification. 

We disagree. Much of EPA's charge is attributable to just 

the point made by the referenced sentence. 

Comment accepted. 

The purpose of these examples is to compare the proposed and 

current RPGs, which are expressed on an annual basis. 

Therefore, the risk is expressed on the same time basis. 

Comment accepted. . 

The text has been modified to address this concern. 

Comment accepted. 

Comment accepted. 

We disagree, for the reasons, among others,, cited in the 

preceding sentence oftthe preamble. 

Rulemaking is clearly included, since this is probably the 

most important of the decision processes referred to in the 

text. Cf. citation of the Administrative Procedures Act in 

the following sentence. 

29] The text has been modified to address this concern.