DISCLAIMER

The following is a staff memorandum or other working document 
prepared for the members of the Advisory Committee on Human
Radiation Experiments.  It should not be construed as representing
the final conclusions of fact or interpretation of the issues. 
All staff memoranda are subject to revision based on further 
information and analysis.  For conclusions and recommendations of
the Advisory Committee, readers are advised to consult the Final
Report to be published in 1995.






TAB H PART 1C

	xx	DRAFT   x    FOR DISCUSSION PURPOSES    xxx

MEMORANDUM

TO:       Members of the Advisory Committee on Human Radiation 
	  Experiments

FROM:     Advisory Committee Staff

DATE:     November 9, 1994

RE:       An Evaluation of Current Environmental Regulations



     This memo combines the concerns articulated in the first memo 
with the facts described in the second.  How well do current 
regulations meet the ethical concerns raised by intentional releases?

I.   FAVORABLE BALANCE OF HARMS AND BENEFITS

     Current substantive and procedural regulations are designed to 
promote a favorable balance of harms and benefits.  It is unclear, 
however, how successfully they achieve this.

     The harm from intentional releases can easily be distributed such 
that no individual has a significant chance of being harmed even 
though it is likely that some in the exposed population will be 
harmed.  For example, if the level of radiation from an intentional 
release posed 1 in 20,000 lifetime risk of induced fatal cancer to 
each exposed individual then the risk to each individual would be 
small.  If, however, the intentional release exposed 100,000 
individuals then we would expect it to cause five fatal cancers.  From 
the perspective of the affected individuals and the total public 
health the effect would be significant.  Most of the substantive 
standards, however, are designed to limit the likelihood that the 
maximum exposed individual will experience harm rather than limiting 
the likelihood of harm to the total population.  Regulations under the 
Clean Air Act, for example, limit the exposure of the maximum exposed 
individual to 10 millirem/year, derived from a standard of 1 in 10,000 
lifetime risk of induced fatal cancer.1 [The Clean Air standards may be 
out of date.  Using BIER V estimates, an annual exposure of 10 millirem/
year would produce 5.6 excess fatal cancers per 10,000, and using the 
UNSCEAR report (1988) would produce a similar estimate.]


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      This has some apparently puzzling consequences.  An air emission 
that exposed one individual to 11 millirem/year would be illegal.  But 
an air emission that exposed 100,000 individuals to 9 millirem/year,
however, would be legal.  The standards for the Atomic Energy Act are 
of the same type--they focus on the likelihood of harm posed to the 
maximally exposed individual rather than the likelihood of harm to the 
total exposed population.

     Guidance within agencies may, however, speak to this problem.  
Guidance within DOE, for example, regulates the collective dose.  
First, any collective dose over 100 person/rem triggers a special 
reporting requirement that forces the facility to report to DOE 
headquarters on reasons for the high collective dose.2 [Duncan Thomas, 
using the BEIR V table, estimates that 100 person/rem would produce 
0.08 excess fatal cancers.  This may be a more stringent requirement 
than the Clean Air Act, depending on the size of the population.]  
Second, internal DOE guidance specifies doses should be "as low as 
reasonably achievable" (ALARA).  The staff does not yet know whether 
other agencies have similar guidelines.  

     National Environmental Protection Act (NEPA) may also speak to 
this problem.  For any major federal action an agency must prepare an 
Environmental Impact Statement (EIS) which compares a proposed course 
of action with alternatives that might affect the environment less 
severely.  This procedural requirement forces agencies to at least 
consider alternatives with lower collective doses.

     Conflicts among the harms and benefits of intentional releases 
may be difficult to adjudicate because of possible incommensurability.  
This issue is, however, addressed by current regulations.  In most 
cases, substantive regulations indirectly protect the environment.  By 
limiting the permissible doses to humans substantive regulations 
invariably limit the level of radiation emitted into the environment.   
These regulations may not protect the environment, however, in very 
remote areas where radiation may have little effect on the maximally 
exposed individual even if it has a significant effect on the 
environment.

     Procedural regulations may go farther to promote concern for 
environmental values.  NEPA directs agencies to independently consider 
environmental effects.  NEPA requires an EIS that conducts not only a 
cost benefit analysis of economic values but also an analysis of 
environmental ones.   The cost-benefit analysis must, "discuss the 
relationship between that analysis and any analyses of unquantified 
environmental impacts, values, and amenities."   Whether forcing 
agencies to consider environmental values in an EIS is sufficient to 
ensure that they give adequate weight to environmental values when 
they adopt policy is, of course, an open question. 

     Environmental regulations also address the conflict between 
national security and other social values.  Each of the environmental 
regulations may be circumvented on the grounds of "paramount national 
interest."  Significant threats to national security, therefore, can 
trump environmental regulations and the environmental values that they 
protect.  But the procedures that allow national security to trump

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environmental values seem to reflect the difficulty of adjudicating 
conflicts between disparate social values.  They remain vague.  What 
constitutes a "paramount national interest" is unclear, and it is 
difficult to predict when, or if, it will be invoked in the future.  

      Internal DOE guidance also attempts to weigh these disparate 
values.  The ALARA "as low as reasonably achievable" standard is 
designed to consider unquantifiable values.  More specifically, 
radiation doses should be as low as social, technical, economic, 
practical, and public policy considerations reasonably permit.  In a 
community which shows extraordinary concern about radiation risks, for 
example, it might be reasonable to put extra efforts into lowering 
emissions.  The community's aversion to radiation risk would be a 
social consideration that would justify lower levels of  radiation.  
If the emission is necessary for national security, however, it might 
be unreasonable to make the same efforts.  National security would be 
a public policy consideration that would justify higher levels of 
radiation.  The DOE official in charge determines what technique is 
used to weigh the competing values and the level of stakeholder 
involvement.  There is no prior review of his decisions, but his 
decisions can be audited after the fact.


II.  SELECTION OF SITE AND QUESTIONS OF JUSTICE

     When an agency selects a site to build a facility capable of an 
intentional release, or when an agency chooses a preexisting site for 
an intentional release, NEPA requires that it provide an EIS.   
Ironically, this might produce perverse incentives.   Public comment 
motivates agencies to consider the public's reaction to any proposed 
action.  When choosing a potential site for an intentional release, 
therefore, the responsible agency would be motivated to choose a site 
that would cause the least public outcry.  The public's response, 
however, may be more a function of how well a community is politically 
organized than of the danger posed by the intentional release.  Thus, 
when choosing a potential site the responsible agency has an incentive 
to choose one in the community that offers the least political 
resistance.  Because more advantaged communities tend to have better 
political organization this incentive may translate into an incentive 
to locate dangerous sites near low income and minority communities.

     Executive Order (EO) 12898 "Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations," however, is designed to prevent such disproportionate 
burdens.  The executive order directs agencies to make achieving  
environmental justice part of their mission.  Whether this executive 
order will be effective is yet to be seen.  The proposed strategy of 
each agency will not be public until February 1995. 

III. LEGITIMACY, AUTHORIZATION, AND CONSENT

     None of the regulations require individual consent.  We might 
interpret some of the provisions, however, as requiring a kind of 
democratic consent.  NEPA requires federal agencies to seek and

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respond to public comments on the environmental effects (including the 
people living in the environment) of their major actions.  The 
government need not do this in any other area of public policy.  It 
does not need to consult the public on economics, on welfare policy, 
on foreign policy, or on housing policy.  The fact that the government 
does consult the public on questions of environmental impact makes 
environmental policy uniquely democratic.  Despite this fact we may 
question whether environmental policy is democratic enough.  While 
NEPA requires agencies to consult with the public it does not require 
that they follow the public's wishes.  There is no requirement that 
the public at large or the members of the public most affected by a 
federal action approve of the federal action.  In addition, NEPA does 
not require public consultation when the federal action concerns 
classified material.  One of the most difficult questions about 
weighing social values--how environmental values should  be weighed 
against the value of national security--is done behind closed doors.

IV.  SECRECY AND DISCLOSURE

     NEPA regulations require agencies to provide the public with 
information regarding any major federal action and to respond to any 
significant public comment.  The implementing regulations read, 
"Request comments from the public, affirmatively soliciting comments 
from those persons or organizations who may be interested or 
affected." Sec 1503.1 (a)(4)  They must also "Make diligent efforts to 
involve the public in preparing and implementing their NEPA 
procedures."  

      The NEPA  regulations do not, however, require public comment 
when the major federal action concerns classified material.  

          Environmental assessments and  environmental impact 
          statements which address classified proposals may be 
          safeguarded and restricted from public dissemination in 
          accordance with agencies' own regulations applicable to 
          classified information.  These documents may be organized so 
          that classified portions can be included as annexes, in 
          order that the unclassified portions can be made available 
          to the public.  Sec. 1507.3 (c)
 
In addition, EO 12898 requires agencies to seek public comment for 
actions that may affect environmental justice. 

V.   PRIOR REVIEW

     Do the current regulations require a proposed intentional release 
to be reviewed by a disinterested third party?  NEPA requires the EPA 
to review major federal actions for their environmental impact.  NEPA 
also requires other agencies with special expertise to review proposed 
actions.   

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          Prior to making any detailed statement, the responsible 
          Federal official shall consult with and obtain the comments 
          of any Federal agency which has jurisdiction by law or 
          special expertise with respect to any environmental impact 
          involved.  

And it must, 

          Obtain the comments of any Federal agency which has 
          jurisdiction by law or special expertise with respect to any 
          environmental impact involved or which is authorized to 
          develop and enforce environmental standards. Sec 
          1503.1(a)(1)  

In most cases this would seem to guarantee a disinterested review by a 
third party.  It might be possible, however, to have the EPA and any 
other agency that has special expertise in a proposed release to have  
a promotional interest in obtaining data.  In addition, even if a 
reviewing agency does not have a promotional interest in the proposal 
other government agencies may be more accommodating then those outside 
the government.  On some issues agencies may have a relationship with 
another part of the government or they may share an assumption that 
the best solution must be some kind of government action rather than 
non-governmental solutions.  In such cases the reviews would not be 
disinterested.

     Both NEPA and EO 12898, however, make public review possible.  
Because some member of the public invariably meets a reasonable 
definition of "disinterested," public review doesn't have the same 
problem with disinterestedness.  Public review, however, might have 
other problems. Because agencies can ignore the public's advice we 
might question its effectiveness.

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