ML20043C209
| ML20043C209 | |
| Person / Time | |
|---|---|
| Issue date: | 05/20/1988 |
| From: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML20042C963 | List:
|
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006040233 | |
| Download: ML20043C209 (3) | |
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g WORKSHOP DN RULES FOR EXEMPTION FROM REGULATORY CONTROL Welcoming Address t
Victor Stello, Jr.
Executive Director for Operations U.S. Nuclear Regulatory Comission it is certainly sty pleasure to welcome all of you on behalf of the United
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States Nuclear Regulatory Comission and specifically Chairman Zech, Comissioners Carr, Rogers, and Roberts.
The subject of exemptions from regulatory control is not a new issue but one which the Comission has typically dealt with over the years on a narrowly defined case by case basis either in its regulations or in specific licensing decisions. The exemptions which exist in NRC's regulations include specified quantities and concentrations of radioactive materials, some of which are contained in consumer products that may be possessed by unlicensed individuals, and in certain waste forms such as liquid scintillation media and animal l
L carcasses containing very low fevels of tritium and carbon 14. just to mention a few examples.
These exemptions were issued by the Comission following evaluations which included qualitative or quantitative cost-benefit analyses.
The exemptions appearing in NRC regulations are issued by the NRC through what is referred to as a rulemaking proceeding. These proceedings assure that public coments are adequately considered.
But many believe, as our l
Comissioners do, that the highly visible needs of today in waste disposal, decomissioning and recycling cannot continue to be served by narrowly defined decisions. A broad policy with an underlying logical consistency is long overdue.
In the past, the Comission has attempted to address the exemption issue on a broader front, but to date with only limited success. About five to seven i
years ago, considerable effort was expended to incorporate a generic dose limit into cur radiation protection standards to avoid extending regulatory actions beyond what is needed to protect public health. In fact, in January of 1986, as a part of a rulemaking proceeding involving a revision of MRC's Standards for Protection Against Radiation, the concept was publicly discussed and such a generic dose limit was proposed. Over the intervening years, the attempt to l.
promulgate this limit into the basic standards has fallen by the wayside.
l Concurrently. in early 1986, the generic exemption issue was also addressed in a different context by our United States Congress through passage of the Low Level Radioactive Waste Policy Amendments Act of 1985.
In this legislation the term *below regulatory concern" was used to address disposal of certain radio-active wastes. These wastes would not need to be subject to regulatory control c-l_
to assure adequate protection of the public health because of their small radioactivity content.
So, over the last few years, new terms have been introduced and new concepts have evolved.
But, over these same years, dollars, francs, pounds, marks, yen, and other currencies continue to flow out in substantial amounts to control I
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uranium mill tailings; to dispose of low-level radioactive waste at licensed disposal sites; to decontaminate sites, material, and equipment used in nuclear activities; and to control radioactivity in consumer products. And all the time we are asking ourselves whether the resources that are being expended to protect the public from overly conservative estimated risk calculations would i
not best be expended in protecting the public from real risks. The fundamental issue is the societal benefit or lack t1ereof from expenditures to regulate such small risks if indeed they are in reality risks!
On the other side of the coin, we have the individual and collective risks associated with these practices: calculated, but as yet scientifically unproved individual risks, which may involve a 1 in a million chance of a
' latent cancer death per year.
As regulators, I believe we must seek some rational balance between these societal risks and the cost of industry and regulatory efforts needed for their control. The Nuclear Regulatory Comission is searching as many of you are, for a solution based on a logical, solid scientific basis. We in the radiation field are not alone.
In fact, 1 believe the control of chemical carcinogens is a similar and perhaps more complex issue.
Here in the United States, our Environmental Protection Agency is struggling with the issue of defining acceptable levels of risk for widely used and beneficial chemicals, as for example, benzene. The Environmental Protection Agency has recently issued for j
public coment four proposals for alternative approaches for controlling benzene emissions. Three of these alternatives are single parameter acceptable risk approaches and include: first, an approach which would tolerate one l
cancer per year to the millions in the United States population who are exposed to benzene; second an approach which would limit the maximum exposed u
individual to a 10 lifetime risk of death. And I want to emphasize the lifetime aspect of this value. And third, an approach similar to the second but where the risk is lowered, yes lowered, by two orders of magnitude to a 10"6 lifetime risk.
By way of comparison, our safety goal for nuclear power 2x10'grsincludesasocietalcompogntwhichhasbeenexpressedintermsofa react annual risk or about a 1x10 lifetime risk. These values or others may be considered too small by some and too large by others, but they must be rationally addressed so that a reasonable and proper expenditure of national resources is achieved.
I understand that considerable progress has been made under IAEA and NEA auspices in addressing this issue.
I have seen several recent reports and cen tell you, as others will at this meeting, that your ideas are being seriously considered in the formulation of a proposed Comission policy.
In fact, our hosting of this workshop reflects the importance that we afford to your views.
But to be successful in formulating a policy, we must speak a comon language i
on this issue. We must understand the various concepts involved. We must air and understand the reasons for any diversity of views among regulators who are charged with protecting public health or the environment. Most importantly, we must be able to convey, to the political authorities and the general public, the prudence and reasonableness of the risk-benefit or other rationale used to justify rediation protection policies in general, and exemption policies in particular. We must do all this in the face of uncertainties in risk associated with radiation at low dose, with the inherent potential uncertainties or conservatisms of many models by which we calculate effects on people, and with an open airing of the regulatory-value judgements which must 2
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be made in balancing costs against benefits. Only in this way can decisions be made which are in the comon national and international interest. The goal must be to weave logical approaches, reasonably conservative models, and sound judgement into a regulatory fabric whose value and usefulness can be widely comprehended. The Comission recognizes that one of its major tasks in establishing a responsible exemption policy is to assess existing diversities in views. To clearly focus on those issues where differences in opinion may exist or specific coments are sought, the Comission has directed that the eforementioned draft Advance Notice of the Development of a Comission Policy You will find on Exemptions from Regulatory Control be made available to you.
that the issues pertaining to " justification of gractice," and "value of or alternatives to use of collective dose criterion are uppemost in the Comission's mind. These issues will be discussed in more detail in our presentation tomorrow morning.
In closing, I have reviewed the agenda of this workshop and believe it is one in which the many facets of regulatory exemption issues, including the ones !
have already mentioned, can be fruitfully discussed.
I would encourage all of I can attest to the fact that within the you to freely express your views.
NRC, over the last several months, wide ranges of opinions have been brought forward, just on the single issue regarding the foundation on which an I would surmise that when a policy is exemption policy should be based.
established, implementation issues will bring out a far wider range of opinions and alternatives.
If we in this industry are allowed one fulfilled dream, let it be a logical exemption policy based on a sound dose response relationship.
I would express the Comission's special thanks to Mr.Ilari and to the speakers and Session Chairmen who have put in the effort to make this Workshop a success.
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