initial step in defining risk analysis, its purposes, and the steps to be followed to ensure that
risk analysis is performed well and is credible.
A document considered to be in the first tier was Executive Order 12866, " egulatory
Planning and Review,"issued by the Office of the President on September 30, 1993, and its
companion document, " conomic Analysis of Federal Regulations Under Executive Order
12866,"issued by the Office of Management and Budget on January 11, 1996 (references
[j] and [k]). One reason for inclusion of this document in the first tier was that the Executive
Order is specifically mentioned in the Risk Principles. However, the primary reason is that
(although it is mandated only for prioritizing regulations) it represents Administration policy
for analyses of this type, and it is the only Government-wide guidance that generically
covers the broad range of activities encompassed by the standard. It contains basic
principles and implementing guidance that go beyond environment, safety, and health
(ES&H) activities to encompass all types of activities. While the Executive Order and its
guidance is mandatory only for the promulgation of formal regulatory requirements by
Government agencies, there is no fundamental difference between this Executive Order
and the self-imposed internal DOE guidelines, procedures, and other directives since DOE
is self-regulating in many of these areas. That is, there is no fundamental difference
between the internal DOE decision process regarding what to do about health, safety,
environment, business practices, contracting, employment practices, etc., and the
promulgation of regulations in these areas by the Nuclear Regulatory Commission (NRC),
the Environmental Protection Agency (EPA), the Occupational Safety and Health
Administration (OSHA), the Department of Commerce, the Department of Labor, and other
Governmental organizations. Therefore, every effort was made to include in this standard
relevant guidelines from the Executive Order and the OMB implementation document.
The second tier of documents used for development of this standard consists of documents
from both the Legislative and Executive branches that have the potential to impact DOE'
use of RBP. These include:
Executive Order 12291, Federal Regulations (reference [i]).
U.S. EPA, " uidelines for Performing Regulatory Impact Analysis"(reference [t]).
U.S. NRC, " evised Guidelines for Performing Value Impact Analysis"(reference [u]).
S.333, U.S. DOE Risk Management Act (reference [q]).
H.R. 1022/H.R.9, Risk Assessment and Cost-Benefit Act (reference [r]).
Unlike the first-tier documents, it was not intended that the standard be consistent with the
second-tier documents since they either did not apply to DOE specifically or were only
proposed. Rather, one reason for including this tier of documents was to see whether they
contained any unique concepts that, if subsequently applied to DOE, could cause a problem
for the guidance in this standard. In addition, other agency guidance was included in the
second tier as these agencies are continuing to have a greater level of regulatory influence
and responsibility over DOE. Finally, proposed legislation was included because it provides
an indication of the concepts that could eventually appear in one or more Congressional
initiatives, and thus was thought that the material in the standard should be compatible with
those concepts to the extent possible. Ultimately, these second-tier documents had virtually
no impact on this standard, as they were not found to contain any concepts that were
counter to those in the first-tier documents nor did they suggest ways to materially
strengthen the standard' approach to achieving full consistency with those documents.
The third tier of documents included "hink tank"reports and existing DOE risk management
documents that have either no regulatory standing, or only as much standing as DOE itself
established. As such, these documents serve only as a source of insight and lessons
learned to provide useful concepts for the standard. These documents include: