1602

alternative regulatory actions, which presumably is the

risk information, it nevertheless uses this information both

in its initial screening of source categories to determine
whether they pose a significant public health risk and in its

process should proceed on the basis of the best information

available for both the public health gains and the economic

costs. A choice can then be made among regulatory alterna-

tives by explicitly considering both the best estimates of the
likely effects of these alternatives and the uncertainties
associated with these estimates.
This approach is superior to a conservative approach that
relies on ‘worst case” estimates of health and economic
effects, because it provides a clear staternent of the likely
effects and uncertainties of the available regulatory alternatives for those making the ultimate policy decisions. Policy
decisions based solely on “worst case” assumptions about
health risks yield “margins of safety” of unknown magnitude — making it impossible to assess the likely gains of
selecting successively more stringent regulatory
alternatives.
- In addition, the direct weighing of the likely public health
gains with the costs in assessing alternatives is, superior to
obscuring the likely effects of regulation by neglecting
information at important steps in the standard-setting process." As we have noted above, EPA’s present BAT approach imparts a conservative bias to the standard-setting
process because it implicitly assumes that the benefits of a
BATlevel of control exceed the costs without regard for the
estimated public health gains, however negligible. In many
cases, however, this implicit assumption appears to be
wrong. An alternative approach that considered both the

-

" The wide range in cost-effectiveness using high and low popula-

tion subcategories results from EPA's determination that BAT
requires the contro! of the secondary emissions from matte and slag
operations at the Kennecott-Garfield smelter. We noted above that
this BAT determination appeared to be inconsistent with EPA's
determination that no further contro] of emissions from converter
operations would be considered to be BAT at this smelter, even

though control of these latter emissions would be more cost-effective. We are not certain, however, of the criteria EPA uses in
arriving at its BAT determinations, and therefore cannot be certain
EPAhas been inconsistent in using these criteria.

1-13-64

recent National Academy of Sciences report recommending a cleat

“_, distinction between assessment of risks and consideration of

risk management alternatives; that is. the scientific findings and

policy judgments embodied in risk assessments should be explicitly
distinguished from the political, economic, and technical considerations that influence the design and choice of regulatory strategies”
National Academy of Sciences, Committee on the Institutional
Means for Assessment of Risks to Public Health, Risk Assessment
in the Federal Government Managing the Process, NAS-NRC,

~
=

March 1983. In our view, this distinction should he maintained in the

analysis of alternative standards. Margin of safety considerations
should be deferred to a later stage in the decision process where the
uncertainties involved can be explicitly considered in designing a

regulatory strategy.

Published by THE BUREAU OF NATIONAL AFFAIAS, INC., Washington. 0.C. 20037

'

“48 FR 33116.

“ EPA uses conservative assumptions in developingits risk information. For example, the quantitative risk estimates developed by
EPAfor these three substances are based on a linear no-threshold
model. EPA states (hat the resulting risk estimate “... represents a
plausible upper-limit estimate in the sense that the risk is probably
not higher than the calculated level and could be much lower.” 48
FR 33114. However, EPA’s quantitative risk assessment is generally based on a specific health effect, e.g, leukernia, without considering other likely health effects, these ought to be considered as well
in assessing the likely public health gains from regulation.
This emphasis on the use of “best” estimates accompanied by
explanations of surrounding uncertainties is an extension of the

|

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ees ee ee

residual risk assessment. At the residual risk assessment

stage, in particular, EPA relies heavily on risk assessment
information by explicitly weighing the likely additional public health gains of going beyond BAT with the costs of a
more stringent standard. The residual risk assessment step
in the siandard-setting process directly considers whether
morestringent controls resuiting in plant closures are warranted — the issue that appears, at least te outsiders, to be
the major economic concern in EPA’s decision process.

we

The use of risk assessment information is critical, in our

view, to making reasonable regulatory judgments. As outlined above, ignoring information about public health risks
at a critical juncture in the standard-setting process results
in standards with costs per health risk reduction that vary
widely across plants and across hazardous substances. In
this section, we discuss the issue of risk assessment more
generallyand consider the use of risk information at other
stages of the standard-setting process. We conclude with
recommendations on the relative weighting to be given to
reduction in individual risk as opposed to the population
risks from exposure to hazardous air pollutants.
1. EPA’s Use of Risk Assessment Information
EPAoffers the following rationale for its use (and nonuse)
of risk assessment information at various stages in the
standard-setting process."*
- The use of risk estimates generally has been confined to
areas of broad comparisons, e.g., in selecting source cate_ gories to evaluate, and in assessing the incremental
change in risk that results from application of various
- control options. The use of risk estimates in an absolute
sense is avoided because of the many uncertainties of the
estimates. These uncertainties are compounded as the
focus is narrowed. In other words, in evaluating specific
sources, aS opposed to source categories, the uncertainties
associated with the risk estimates increase dramatically.
Although EPAstresses the uncertainty associated with its

Thereis, of course, some uncertainty associated with the

risk information, just as there is some uncertainty with
EPA's cost estimates." We believe that the decision-making

”

D. Use of Risk Assessment Information in Standard-Setting

a> ne OT alg ove ET Caoneatslemme

each plant within a subcategory.”

in setting technology-based (BAT) standards is to risk imposing regulatory requirements arbitrarily, and expending
scarce resources without any commensurate gains in public
health.

”

determination of the level of control constituting BAT for

issue of primary concern. Acting without such information

:
‘
meavie
aE Kahl tee gd a4 a
* wertwe es Fea

of control requirements; but a sensible result depends on the

:

risk may serve to narrow the range in the cost-effectiveness

other stages as well. After all, the risk information is the
best information available on the public health effects of

*

category on the basis of population exposure or public health

high and Jow population or risk groups does not automatica)ly yield a sensible result. Sebcategorization of a source

hin

Since EPA uses risk information at this critical juncture
in the decision process, it should use risk information at

ty, oe my

As these examples illustrate, taking risk and population

exposure into consideration by subcategorizing sources into

Bat]

ENVIRONMENT REPORTER

Select target paragraph3