ENVIRONMENTAL RISK AND COST-BENEFIT ANALYSIS: A REVIEW OF PROPOSED LEGISLATIVE MANDATES, 1993-1998

CRS Report for Congress
Environmental Risk and Cost-Benefit Analysis:
A Review of Proposed Legislative Mandates,
1993-1998
January 22, 1999
Linda-Jo Schierow
Specialist in Environmental Policy
Environment and Natural Resources Policy Division


Congressional Research Service ˜ The Library of Congress

ABSTRACT
Between 1993 and 1998 Congress considered many proposals that aimed to increase or
improve the use of risk analysis by federal agencies, especially in developing environmental
rules. This report describes differences and similarities among selected provisions of keyrd
proposals: Senate-passed Johnston amendments to S. 171 and S. 2019 in the 103 Congress;th
S. 343, as reported by the Committee on the Judiciary, in the 104 Congress; House-passedth
H.R. 9 in the 104 Congress; S. 981, as reported by the Committee on Governmental Affairs,thth
in the 105 Congress, and S. 1728, as introduced, in the 105 Congress. This report will not
be updated. Issues related to EPA's use of risk analysis are analyzed in CRS Report 98-618,
Environmental Risk Analysis: A Review of Public Policy Issues. For current information
about legislation, see CRS Issue Brief 94036, The Role of Risk Analysis and Risk
Management in Environmental Protection. For a broader look at regulatory reform
initiatives targeting environmental regulations, see CRS Report 96-949, Environmentalth


Reauthorizations and Regulatory Reform: From the 104 Congress to the 106th.

Environmental Risk and Cost-Benefit Analysis:
A Review of Proposed Legislative Mandates, 1993-1998
Summary
Between 1993 and 1998 Congress considered many different proposals that
aimed to increase or improve the use of risk analysis and cost-benefit analysis by
federal agencies, especially in developing environmental rules. Key proposals include:
the Senate-approved Johnston amendments to S. 171, a bill to confer cabinet-level
status on the Environmental Protection Agency (EPA), and to S. 2019, a bill to
reauthorize the Safe Drinking Water Act, in the 103 Congress; S. 343, as reportedrdth
by the Committee on the Judiciary, in the 104 Congress; Divisions C and D of H.R.

9, as passed by the House, in the 104 Congress; S. 981, as reported by theth


Committee on Governmental Affairs, in the 105 Congress; and S. 1728, asth
introduced, in the 105 Congress. th
From the 103 to the 105 Congress, proposals broadened in scope tordth
encompass more federal agencies and more kinds of agency activities. At the same
time, recent proposals apply to a smaller fraction of promulgated rules that are
“major,” rather than to all final rules. All highlighted proposals mandate risk analysis
when environmental regulations are promulgated, and the specificity of proposed
requirements grew in each Congress. Similarly, all the highlighted bills, with one
exception, mandate analysis of the costs and benefits of some new rules, and these
requirements have been elaborated in each consecutive Congress.
Most of the six highlighted bills would have established economic criteria for
evaluating and choosing among regulatory options. Four of the six bills would have
directed agencies to promulgate cost-effective rules. Four bills also would have
advised or required that benefits of a rule should justify its cost. Other proposed
criteria included: flexibility to regulated entities and governments, net benefits,
incremental costs and benefits, and costs. However, only the bills of the 104th
Congress explicitly would have prohibited promulgation of a rule unless economic
criteria were met.
Three of the highlighted proposals would have directed the executive branch to
coordinate and oversee regulatory analyses by agencies, but limited the time for
review and required public disclosure of relevant communications with the regulatory
agency and others outside of the federal government. Two of these bills also would
have required peer review to ensure the quality of agencies’ analytic work. Allthth
highlighted Senate bills in the 104 and 105 Congresses would have suspended
deadlines to facilitate agency compliance with analytic requirements for rules. Most
of those bills would have required agencies to review existing major rules, as well as
newly promulgated rules. Other provisions of bills in the 104 Congress that wouldth
have authorized citizen petitions and judicial review or required risk-based budgeting
were eliminated or modified in bills of the 105 Congress. th
Proposed mandates for risk analysis and cost-benefit analysis of environmentalrd
rules became more complex after the 103 Congress, as they included more
exceptions and caveats for analytic requirements and decision rules, as well as more
mechanisms to ensure the quality of analyses.



Contents
Introduction ................................................... 1
Key Legislative Proposals.........................................2

103 Congress..............................................2rd


104 Congress..............................................3thth


105 Congress..............................................3
Comparison of Selected Provisions..................................4
Applicability ............................................... 4
Analytic Requirements........................................5
Regulatory Decision Criteria...................................6
Effect on Existing Law.......................................7
Coordination and Quality Control...............................8
Executive Oversight......................................8
Peer Review............................................8
Other Provisions............................................8
Deadlines .............................................. 9
Review of Rules.........................................9
Citizen Petitions.........................................9
Judicial Review.........................................9
Risk-Based Priorities.....................................9
Conclusion ................................................... 10
List of Tables
Table 1. Decision Criteria Employed by Key Proposals in the 103, 104, and 105rdthth
Congresses
......................................................... 7rd th th


Table 2. Cost-Benefit Analysis in the 103, 104, and 105 Congresses.....11

Environmental Risk and Cost-Benefit Analysis:
A Review of Proposed Legislative Mandates,
1993-1998
Introduction
The 103, 104, and 105 Congresses considered whether to require riskrdthth1
analysis of environmental regulatory proposals by the U.S. Environmental Protection
Agency (EPA) and other agencies. The House and Senate each approved at least one
such proposal (see below). But, so far no Congress has enacted a requirement for
risk analysis that would change the way all environmental (or health and safety)
regulations are developed. It is not clear whether any comprehensive requirement for
risk analysis of environmental regulations will be considered by the 106 Congress.th
Some believe that more recently evolved proposals lack most of the provisions that
historically have been stumbling blocks to passage, and they see a gathering
momentum for a legislative mandate. Others see waning congressional interest.
At some point, however, Congress is expected to debate again an overarching
mandate for risk analysis of environmental regulations. Many believe that
environmental programs could be more efficient and flexible, and less costly to the
regulated community, if EPA considered the results of risk analysis. Others disagree,
arguing that such analyses use scarce agency resources, delay rulemaking, and force
decisions to conform to the analytic results, regardless of the quality of underlying
data and models. The issues and legislative options surrounding the use of risk
analysis at EPA are described and analyzed in CRS Report 98-618, Environmental
Risk Analysis: A Review of Public Policy Issues.
Proposed mandates for risk analysis must be considered in the context of
existing and perhaps past mandates, as well as agencies’ practices. Executive orders,
environmental statutes, and other provisions of law authorizing, mandating, or
constraining EPA’s use of risk analysis are discussed in CRS Report 98-619, Risk
Analysis: Background on Environmental Protection Agency Mandates.


“Environmental risk analysis” refers to any quantitative or qualitative scientific1
description of an environmental hazard, the potential adverse effects of exposure, the risks of
these effects, events and conditions that may lead to or modify adverse effects, populations
or environments that influence or experience adverse effects, and uncertainties with regard to
any of these factors. For a more detailed definition, see the Appendix to CRS Report 98-618,
Environmental Risk Analysis: A Review of Public Policy Issues.

This report describes and compares selected provisions related to risk analysis
in key legislative proposals introduced from the 103 through the 105 Congresses,rdth
including:
!the Johnston amendments to S. 171, a bill to confer cabinet-level status on the
Environmental Protection Agency (EPA), and to S. 2019, a bill to reauthorize
the Safe Drinking Water Act, both as passed by the Senate in the 103rd
Congress; th
!S. 343, as reported by the Committee on the Judiciary, in the 104 Congress;
!Divisions C and D of H.R. 9, as passed by the House, in the 104 Congress;th
!S. 981, as reported by the Committee on Governmental Affairs, in the 105th
Congress, and th
!S. 1728, as introduced, in the 105 Congress.
The comparison emphasizes differences among provisions related to risk analysis and
cost-benefit analysis and mechanisms such as judicial review or peer review that make
agencies more accountable for the quality of such analyses.
This report focuses on the general provisions of highlighted sections of bills
that are large and complex; specific provisions that modify the general requirements
of the highlighted sections may be omitted.
Key Legislative Proposals

103 Congressrd


More than a dozen bills and amendments on environmental risk analysis were
introduced in the 103rd Congress. One, P.L. 103-354, was enacted, but it applied
only to the Department of Agriculture. Nine other bills were passed by one chamber
or reported by the committees of jurisdiction.
Arguably, the most influential risk proposals in the 103 Congress were tword
amendments offered by Senator J. Bennett Johnston. The original “Johnston
amendment” was the first risk legislation debated on the Senate floor, and it was
adopted on April 29, 1993, by a vote of 95 to 3. The amendment was incorporated
as Section 123 in S. 171, a bill to raise the U.S. Environmental Protection Agency
(EPA) to department (cabinet) status. In the House, a proposal to similarly amend
a bill to elevate EPA to the cabinet (H.R. 3425) was unsuccessful, however. The rule
for consideration of the reported House bill was defeated on the floor, reportedly in
part because the rule would have prevented introduction of non-germane
amendments, such as one on risk and cost-benefit analysis.
During the second session of the 103rd Congress, Senator Johnston addressed
some of the key concerns of Members when he introduced a revised version of his
amendment. It was adopted by the Senate during the May 18, 1994 floor debate on
Senate-passed S. 2019, a bill to amend and reauthorize the Safe Drinking Water Act.
The amendment became Section 18 of the Senate-passed bill. Section 15, S. 2019,



as passed by the Senate, also included a revised version of a bill originally introduced
by Senator Moynihan (S. 110) that would have required EPA to rank pollution
sources based on risk. These bills did not receive House action.

104 Congressth


Three risk-related bills were reported to the Senate in the 104 Congress (S.th
291, S. 333, and S. 343). In June, 1995, they were merged and introduced on the
Senate floor by Senator Dole as a substitute amendment for S. 343, as reported by the
Committee on the Judiciary. After two weeks of debate and three failed votes to
invoke cloture, the Senate turned to other issues. The reported bill (also known as
the Dole bill), rather than the substitute amendment, is summarized in this report.
The House Republican Contract with America promised that within the first
100 days of the 104th Congress risk legislation would be introduced, debated, and
voted upon in the House. Title III of the “Job Creation and Wage Enhancement Act
of 1995" (JCWEA), one of the draft bills distributed with the House Republican
contract, appeared to integrate several of the proposals related to risk analysis that
saw action in the 103rd Congress, including a slightly modified version of the original
Johnston amendment, with coverage expanded beyond EPA to include all federal
agencies that promulgate regulations concerning human health and safety or the
environment. The House amended and passed these provisions in H.R. 9 on March

3, 1995.


H.R. 9, as passed by the House, contained four divisions, A through D. Each
division contained the text of a bill that had passed the House prior to consideration
of H.R. 9. Division C and Division D had provisions related to risk analysis. Division
C contained the text of H.R. 926, the Regulatory Reform and Relief Act, while
Division D had the text of H.R. 1022, the Risk Assessment and Cost-Benefit Act of

1995. The Senate did not act on H.R. 9.


Although the 104 Congress adjourned without enacting comprehensiveth
requirements for risk analysis, Congress did enact risk-based provisions included in
major legislation addressing drinking water (P.L. 104-182) and food safety (P.L. 104-
170), as well as requirements for economic analysis, which for environmental
regulations requires some analysis of risks as a basis for calculating risk reduction
benefits (P.L. 104-4; P.L. 104-121, Title II). None of these mandates for risk analysis
is compared in this report.

105 Congressth


The 105 Congress considered various proposals that would have mandatedth
analysis of environmental risks, but adjourned without enacting comprehensive
regulatory reform legislation or other provisions that would have increased use of risk
analysis by EPA. The most comprehensive bill, S. 981, as reported by the Senate
Committee on Governmental Affairs, had bipartisan support (S. Rept. 105-188), but
also faced significant opposition. The Senate Committee on Governmental Affairs
reported S. 981, the Regulatory Improvement Act of 1998, amended, on May 11,

1998, but the bill received no floor action. The Majority Leader introduced a risk-



only version of S. 981, S. 1728, that would have applied only to proposed and final
regulations to protect health, safety, or the environment with a potential annual cost
to the economy of $100 million or more.
Comparison of Selected Provisions
In general, bills mandating risk analysis have become more complex and
detailed since 1993. Table 2 summarizes selected provisions of key bills in the 103,rdthth
104, and 105 Congresses, beginning on page 11
Applicability
From the 103 Congress to the 104 Congress, proposed mandates for riskrdth
analysis in the federal government have broadened in scope to encompass more
agencies. The Johnston amendments would have mandated risk analysis only by EPA,th
while proposals in the 104 Congress would have targeted all federal agencies,
including the independent boards and commissions which, unlike other federal
agencies, have never been required by executive order to perform risk analysis or
economic analysis for proposed or final rules. 2
It is not clear whether bills in the 105 Congress would have required moreth
or fewer risk analyses and economic analyses by individual agencies than those in the

104 Congress. The Johnston amendment to S. 171 would have applied only to finalth


rules that related to human health and safety or the environment, while later legislation
would have mandated analysis of proposed as well as final rules, and (with theth
exception of S. 1728 in the 105 Congress) would have covered rules for any
regulatory purpose. 3
Moreover, although the proposed bills generally would have affected all
substantive rulemaking (that is, rule development for all rules covered by the notice
and comment requirements of the Administrative Procedure Act), some proposals inthth
the 104 and 105 Congresses would have affected additional activities. For example,
under S. 343, risk analyses not connected with rulemaking would have been affected
as well as interpretive rules or rules of agency organization, procedure, or practice,
if they had altered or created rights or obligations of persons. Similarly, S. 981 would
have affected risk characterizations in risk assessment documents and agency
decisions, as well as regulatory proposals. S. 1728 would have required analyses4
when a significant substitution risk resulted from promulgation of a rule.


President Reagan issued the first explicit mandate for regulatory risk analysis in2
January 1985. For more information about the requirements of executive orders, see CRS
Report 98-619, Risk Analysis: Background on Environmental Protection Agency Mandates.
S. 1728, like the Johnston amendment to S. 171 in the 103 Congress, targets only3rd
rules for which the primary purpose is to address health, safety, or environmental risks.
“Risk characterization” is the final step in a risk analysis, which summarizes scientific4
judgments about the existence and overall magnitude (that is, the incidence) of adverse effects,
given specified levels of exposure to a hazard.

Proposals in the 104th and 105th Congresses would have applied only to rules
with a “major” or “significant” impact on the economy, health, the environment, or
public policy. In contrast, the Johnston amendment to S. 171 in the 103 Congressrd
applied regardless of the impact of a rule. Under the Johnston amendment to Senate-
passed S. 2019, analysis would be required only for rules with an annual effect on the
economy of $100 million or more. In the 104 Congress, S. 343 and H.R. 9 Divisionth
C would have applied to rules with an estimated cost of $50 million or more in a year,
while H.R. 9 Division D would have affected rules likely to cost $25 million or more.th
In the 105 Congress, both S. 981, as reported, and S. 1728, as introduced, would
have applied to rules likely to have a gross annual cost of $100 million or more.
Definitions of “major rules” and “significant risk assessments” also varied in
the amount of discretion they would have provided to the Office of Management and
Budget (OMB) to designate rules as major or non-major. Rules likely to result in
major increases in costs or prices or significant adverse effects on economic activity
could have been designated as major under any of the legislative proposals in the 104thth5
and 105 Congresses. The Senate bills during this period also would have authorized
designation of a rule as major due to its effects on health, safety, or the environment.
S. 981 would have given OMB the authority to require a risk analysis to comply with
proposed requirements.
All of the proposed mandates, except the Johnston amendments, authorized
exemptions for certain types of rules. For example, S. 343, H.R. 9 Divisions C and
D, S. 981, and S. 1728 would have provided for emergencies, while S. 343, H.R. 9
Division D, and S. 981 would have exempted from risk analysis requirements rules
approving product labels (e.g., for pharmaceutical drugs). S. 171 and S. 2019 would
have required EPA to perform the analyses or to report the reasons for
noncompliance in the Federal Register and to Congress.
Analytic Requirements
All of the proposals would have required agencies to analyze risks when they
are developing rules, generally before the risk is addressed by the regulation, relative
to other risks that could be addressed, and after a risk is managed under the rule to
estimate the incremental amount of risk reduction that might be achieved. For
example, the Johnston amendment to S. 171 would have required analyses of:
!risks to individuals addressed by the regulation;
!the health and environmental effects of the regulation; and
!risks addressed compared to other risks.
S. 2019 added a requirement to analyze risks to “significant subpopulations
disproportionately exposed or particularly sensitive.” It also explicitly required
qualitative analysis as well as quantitative analysis of risks.


The language used to define a “major rule” is precise and meaningful. Note that the5
number of rules with an “effect on the national economy” of a certain monetary value is likely
to be much greater than the number of rules with a “cost” of equal value.

H.R. 9 and S. 343, as reported in the 104 Congress, would have includedth
requirements to analyze uncertainties, assumptions, the distribution of risk in a
population (that is, who is at risk), substitution risks (risks resulting from regulation),
and the likelihood that exposure to risks would occur. All these analytic requirements
were included in S. 981 (105th Congress).
Beginning in the 104 Congress, proposals specified certain principles of riskth
analysis to which covered agency analyses and presentations of results would be
required to conform. The bills proposed various means of estimating and then
expressing risk: in the 104 Congress, agencies would have been directed to useth
“plausible” or “unbiased” models and to present a “best estimate”; S. 981 would have
mandated a “weight of scientific evidence” approach and expression of a central and
high end risk estimate; and S. 1728 would have required public input and statement
of the “most plausible” risk estimates.
Analysis of costs and benefits would have been mandated by all the highlightedth
bills (except the bill introduced by Senator Lott late in the 105 Congress), but the
bills differed in how they would have directed agencies to relate costs and benefits.6
Both versions of the Johnston amendments (103 Congress) and S. 343 (104rdth
Congress) would have required consideration of whether benefits would justify costs.th
S. 343 and S. 981 (105 Congress) would have mandated analysis of net benefits
explicitly. S. 2019 and S. 981 in the 105 Congress also would have required a cost-th
effectiveness analysis.
Additional elements of economic analysis were added to bills in the 104th
Congress. Both S. 343 and H.R. 9 would have required analysis of the distribution
of costs and benefits, incremental costs and benefits, effects on small businesses, and
the cumulative cost to the regulated community and comparison of all these measures
for all specified alternatives to the proposed or final rule. S. 343, but not H.R. 9,
would have directed EPA to assess net benefits, net costs, and net effects on small
businesses. H.R. 9 would have mandated analysis of whether benefits would exceed
costs.
S. 981, in the 105 Congress, would have added requirements to analyze theth
feasibility of using market-based mechanisms, the flexibility provided to local and state
governments and the regulated community, and the quality of information. S. 981,
like S. 343 before it, specified certain principles of economic analysis.
Regulatory Decision Criteria
Except for S. 1728 (105 Congress), all of the highlighted bills would haveth
established criteria for evaluating and choosing among regulatory options, based on
analytic results. Excluding S. 1728, the bills would have established economic criteria
which are summarized in Table 1. Both Johnston amendments, S. 343, and S. 981
would have directed EPA to consider whether benefits would justify costs. The


The Unfunded Mandates Reform Act (P.L. 104-4) requires federal agencies to analyze6
costs and benefits of all proposed and final rules with an expected cost of $100 million or
more.

Johnston amendment to S. 2019 also would have required a rule to be most cost-
effective. S. 343 would have required a rule to be most cost-effective or least-cost.
S. 981 would have required a determination as to whether the rule was most cost-
effective or provided the greatest net benefits. Finally, H.R. 9 would have mandated
rules that were most cost-effective or provided more flexibility and that had
incremental benefits likely to justify and be reasonably related to the incremental
costs. 7
Table 1. Decision Criteria Employed by Key Proposals in the 103,rd

104, and 105 Congressesthth


Decision CriteriaS. 171S. 2019S. 343H.R.S. 981S. 1728
9
Benefits justify costsXXXX
Most cost-effectiveXXXX
Least costX
Greatest net benefitsX
FlexibleX
Incremental costs — X
incremental benefits
Effect on Existing Law
Arguably, the highlighted bills of the 103 and 105 Congresses would notrdth
have superseded other provisions of federal law, such as the Clean Air Act or the
Safe Drinking Water Act, with regard to how EPA should weigh costs and risks in
developing regulations. Neither would they have authorized EPA to employ risk-
based or economic criteria when implementing other statutes, some argued.
Nevertheless, this apparent neutrality with respect to existing law was made more
explicit, as time passed: the amendment to S. 2019 was more explicit than that to S.

171; and in the 105 Congress, S. 981 provided still greater assurance that itsth


requirements would apply only to the extent that they were not inconsistent with
existing statutes. However, the neutrality of proposed requirements relative to
existing statutory requirements never was stated absolutely clearly, according to some
observers. S. 1728 would not have established decision criteria, so its analytic
requirements apparently would not have conflicted with existing legal requirements.
In contrast, S. 343 explicitly would have prohibited promulgation of a rule
unless decision criteria were met (that is, benefits justified costs, and the rule was the


The Unfunded Mandates Reform Act (P.L. 104-4) enacted by the 104 Congress7th
requires federal agencies, except for independent regulatory boards and commissions, to
promulgate the alternative that is least costly, most cost-effective, or least burdensome, or to
explain why such an alternative was not adopted.

most cost-effective or least-cost alternative). Similarly, H.R. 9 Division D would
have superseded provisions of existing laws and prohibited promulgation of a major
rule, unless incremental benefits were likely to justify and be reasonably related to the
incremental costs, and alternatives were either less cost-effective or provided less
flexibility to regulated entities or local or state governments.
Coordination and Quality Control
Executive Oversight. OMB has been overseeing cost-benefit analyses of
regulations under the authority of executive orders since President Reagan issued
Executive Order 12291 in 1981. In contrast, OMB has no clear authority to oversee
risk analyses, except to the extent that they underlie benefit analyses for regulations
under review.
Three of the bills highlighted in this report (S. 343, H.R. 9, and S. 981) would
have authorized executive branch oversight of agencies’ regulatory analyses and
mandated issuance of guidance for the conduct of economic and risk analyses. Two
(H.R. 9 and S. 981) would have assigned these tasks to OMB. Only economic
analyses of regulations would have been reviewed under H.R. 9, but OMB would
have been required to approve or comment on a final cost-benefit analysis prior to
promulgation of a major rule. S. 981 would have authorized OMB oversight for risk
assessments and peer review, as well as economic analyses. H.R. 9 would have
required OMB to evaluate federal agencies’ rulemaking procedures, while S. 981
would have directed OMB to evaluate agencies’ cost-benefit and risk analyses
periodically.
As a check on the new statutory authority of OMB to oversee regulatory
proposals, S. 981 and H.R. 9 would have limited the time for OMB review to 90 days,
while S. 343 permitted only 30 days, but all three bills would have allowed the period
to be extended. In addition, S. 981 would have required public disclosure of any
changes to regulatory proposals that resulted from the review, and a written record
of relevant contacts OMB had with the regulatory agency and persons outside the
executive branch. H.R. 9 also required a written record of relevant contacts made
with persons outside the agency.
Peer Review. Peer review was another mechanism proposed to ensure the
quality of agencies’ analytic work and the scientific soundness of decisions. S. 343th
in the 104 Congress, relied most heavily on peer review, as it would have required
peer review of agencies’ analyses for major new rules, reviews of analyses for
existing rules, risk estimates supporting database entries, and clean-up plans for
hazardous waste sites. Also in the 104 Congress, H.R. 9 would have required peerth
review of analyses for major rules worth at least $100 million and of other analyses
designated by OMB. In the 105 Congress, S. 981 would have required peer reviewth
only for major rules. Neither the Johnston amendments in the 103 Congress nor S.rd

1728 in the 105 had any provision regarding peer review or oversight by theth


executive branch of government.



Other Provisions
Deadlines. Statutory and judicial deadlines for promulgation of rules were
treated in various ways by the bills of interest. The original Johnston amendment was
silent on the subject of deadlines. Risk analysis requirements imposed by the Johnston
amendment to S. 2019 and H.R. 9 would have been waived or deferred when there
was a conflicting statutory or judicial deadline. In contrast, S. 343, S. 981, and S.
1728 would have suspended deadlines to allow compliance with requirements for
regulatory analysis.
Review of Rules. Only S. 343, H.R. 9, and S. 981 would have required
agencies to review existing major rules. Under S. 343, all existing rules would have
terminated in 7 years unless they were reviewed by the administering agency.
Citizen Petitions. Bills in the 104 Congress would have authorized citizenth
petitions for judicial review of agency compliance with analytic requirements. In
addition, S. 343 would have provided broad authority for citizen petitions to force
agencies to examine and redesign rules so that they conformed to decision criteria.rdth
Bills in the 103 and 105 Congresses did not provide for citizen petitions.
Judicial Review. Proposals differed widely in their treatment of judicial
review. The Johnston amendments in the 103 Congress would not have subjectedrd
either the compliance of agencies with analytic requirements nor the analyses
themselves to judicial review.
In the 104 Congress, S. 343, as reported, would have subjected all agencyth
decisions regarding rules, orders, petitions, licenses, sanctions, or relief to judicial
review, and it would have established a new set of standards for judicial review,
including that there is “substantial support in the rulemaking file for the factual basis
of agency actions.” H.R. 9 Division D would have directed courts to consider agency
actions unlawful solely on the basis of a significant risk characterization or risk
analysis in the rulemaking record that did not substantially comply with the proposed
requirements.
In the 105 Congress, S. 981, as reported, would have permitted review ofth
agency compliance with analytic requirements only in connection with review of a
final agency action. S. 1728 also would have subjected to judicial review agency
decisions about which rules are major, and agency risk analyses in connection with
review of a final agency action. Both bills in the 105 Congress would have requiredth
only that the rule not be arbitrary or capricious or an abuse of discretion (or
unsupported by substantial evidence where that standard otherwise was provided by
law), that the agency performed requisite analyses, and (under S. 1728), that
designation of a rule not be “clearly and convincingly” erroneous.
Risk-Based Priorities. Several of the highlighted bills would have promoted
use of analytic results to prioritize regulatory efforts within agencies: S. 343 would
have required agencies to reflect risk-based priorities in annual budget requests; H.R.
9 would have required that relative risks and cost-effective risk reduction strategies
be identified within regulatory programs; and S. 981 would have required agencies to
inform annual budgets and strategic plans and performance plans with the results of



a study by a scientific institution of relative risks and strategies for reducing them. S.

1728 in the 105 Congress had no comparable provision, and the Johnstonth


amendments in the 103 Congress did not mention the setting of priorities. rd8
Conclusion
A comparison of selected provisions of key legislative proposals mandating
risk analysis and cost-benefit analysis of environmental regulations indicates that
proposals broadened in scope to encompass more federal agencies and more kinds of
agency activities. At the same time, the more recent proposals apply to a smaller
fraction of promulgated rules that are “major,” often defined as a rule with an annual
cost of at least $100 million.
Most of the highlighted bills would have required economic analysis, as well
as risk analysis, and would have established economic criteria for choosing among
regulatory options. The preferred option typically was the most cost-effective
alternative and one that would have produced benefits justifying costs. Such
requirements became more specific and increased in number between 1993 and 1998.
Proposals also became more complex as legislators tried to ensure that
unintended adverse consequences of an overarching mandate (e.g., delayed
rulemaking in emergencies) would be avoided. Thus, each Congress considered more
exceptions and caveats for analytic requirements and decision rules. At the same time
(perhaps to compensate), proposals included more mechanisms to ensure the quality
of analyses. Compared to key proposals in the 104 Congress, the moreth
comprehensive proposal in the 105 Congress, S. 981, as reported, would haveth
reduced reliance on judicial review while leaning more heavily on peer review and
executive oversight of analyses. Executive branch reviews of agencies' rules generally
would have been limited to 90 days and the substance of communications between
OMB and the regulatory agency or between OMB and anyone outside of government
about rules under review would have had to be disclosed to the public.


However, S. 2019 Section 15 would require a report of the relative risk of various8
sources of pollution and of the costs and benefits of risk reduction strategies.

Table 2. Cost-Benefit Analysis in the 103, 104, and 105 Congressesrdthth9
Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Affected AgenciesU.S. EnvironmentalAll federal agenciesRulemaking: All federalAll federal agenciesAll federal agencies
Protection Agency (EPA)agencies
Risk analysis: EPA,
ACOE, CPSC, DOE,
DOI, DOT, FDA, MSHA,
NOAA, NRC, OSHA,
USDA, and other agen-10


cies designated by OMB
iki/CRS-RL30031
g/w
s.or
leak
://wiki
http
Because the report omits specific provisions that modify general requirements of the highlighted sections, reference to the bills themselves is advisable. 9
The affected agencies are: Environmental Protection Agency (EPA), Army Corps of Engineers (ACOE), Consumer Product Safety Commission (CPSC), Department of Energy10
(DOE), Department of Interior (DOI), Department of Transportation (DOT), Food and Drug Administration (FDA), Mine Safety and Health Administration (MSHA), National
Oceanographic and Atmospheric Administration (NOAA), Nuclear Regulatory Commission (NRC), Occupational Safety and Health Administration (OSHA), United States Department
of Agriculture (USDA), and other agencies designated by the Office of Management and Budget (OMB).

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Rules and OtherS. 171 — Final rulesVaries section by section.,Division C —Substantive rules, excludingSubstantive rules the
Products orrelating to human healthbut generally applies to allSubstantive rules,rules required to be issuedprimary purpose of which
Activities Affected and safety or thegenerally applicable rules,excluding rules issued inannually; authorizingis to address health,
environment including substantivean emergency, under aintroduction into commercesafety, or environmental11
rules; interpretive rulesdeadline, or to implementof food, drugs, or cosmetics;risks; excludes the same
S. 2019 — Proposed andor rules of agency organi-tax laws or internationalissued by the Federalrules excluded by S. 981,
final major rules relatingzation, procedure, orsanctionsElection Commission or inexcept does not exclude
to human health or thepractice that alter or createsome cases by the Federalrules authorizing
environmentrights or obligations ofDivision D — GenerallyCommunicationsintroduction into
persons outside theapplicable rules,Commission; or affectingcommerce of food, drugs,
agency; and rules per-including substantivetax, monetary policy,or cosmetics
taining to agency acquisi-rules; excepts rulessecurity brokers and
tion, management, or dis-issued in an emergency,dealers, or bank safety orRisk analyses for major
posal of property or ser-approving food, drug orsoundness rules relating to human
vices if not by GSA other product labels,health or the environment
procedures; excepts rulesapproving state programs,Economic analyses of newand for rules that result in
pertaining to military oror relating to militarymajor rules a significant substitution
iki/CRS-RL30031foreign affairsreadiness, healthrisk
g/winsurance, or medicalservices


s.or
leak
://wiki
http
Substantive rules are those rules for which agencies are required to provide public notice of rulemaking and opportunity for public comment under the Administrative11
Procedure Act (5 U.S.C. 553). They exclude rules pertaining to military or foreign affairs, agency management or personnel or to public property, loans, grants, benefits, or
contracts. Except when notice and comment is otherwise required by law, this category also excludes interpretative rules, general statements of policy, rules of agency
organization, procedure, or practice, and rules for which the agency finds for good cause that notice and public comment procedures are impracticable, unnecessary, or contrary
to the public interest.

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Affected ActivitiesPolicy statements thatRisk analyses andRisk analyses in
(cont.)alter or create rights orcommunications inconnection with
obligations of persons
outside the agencysupport ofmajor rules
Economic analyses for“significant” riskaddressing health,documentssafety, or
new major rules, cleanup
plans, and reviews ofenvironmental risks,
existing rules; exceptsand other risk
analyses in emergencies,analyses designated
for rules authorizing or12
recognizing a commercialby OMB; excepts
product, for inspecting oranalyses for emer-
permitting facilities,gencies, inspecting or
registering pesticides,
reviewing toxicitypermitting facilities,
information forscreening analysis, or
iki/CRS-RL30031commercial chemicals,product labels
g/wsetting limits for pesticideresidues in food, screening
s.oranalysis, or product labels
leak Risk
Risk analyses andcharacterizations in
://wikicharacterizations inrisk assessment
httpconnection with health,safety, or environmentaldocuments,
risks, excluding those thatregulatory proposals,
support approval of newor decisions by
products or permittingcovered agencies


actions, screening
analyses, inspections or
enforcement actions
This would be a new authority for OMB. Current practice and provisions proposed in all the above abstracted bills from the 104 and 105 Congresses provide OMB12thth
with the authority to designate rules to be treated as major, but no other bill confers such power with respect to risk analyses.

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Major Rules S. 171 — NotCovered rules withDivision C —Substantive rulesSame as S. 981
applicablean estimated cost ofSubstantive ruleslikely to have a gross
$50 million or morelikely to result in anannual cost of $100
S. 2019 — Rulesin a year, or withannual effect on themillion or more, or to
that may have anspecified significanteconomy of $50result in other
effect on theadverse effects onmillion or more,specified significant
economy of $100economic activity,major increases inadverse effects on
million or more ininnovation, health,costs or prices, oreconomic activity,
any one yearsafety, or thesignificant adverseinnovation, public
environment;effects on economichealth, safety, the
excluding tax rulesactivity orenvironment, state,
and rules approvinginnovationlocal, or tribal
iki/CRS-RL30031or removing agovernments, orproduct inDivision D —communities
g/wcommerceRules likely to
s.or
leakresult in an annual
increase in costs of
://wiki$25 million or
httpmore; excepts rules
approving products
or substances



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Mandates forS. 171 — For finalFor proposed andDivision C — ForFor major new rules,No provision
Economicrules relating tofinal major rules,major proposed oragencies must
Analysis health and safety ormajor cleanup plans,final rules, agenciesanalyze benefits;
the environment;and existing rulesmust analyze costs,costs; benefits
agencies mustbeing reviewed,benefits, andrelative to costs;
analyze costs,agencies mustdistribution of costscost-effectiveness;
benefits, andanalyze costs,and benefits for thenet benefits; a
whether benefitsbenefits, incrementalproposal and less-reasonable number of
will justify costscosts and benefits,cost alternativesreasonable
feasibility ofalternatives;
specifiedDivision D — Forfeasibility of using
S. 2019 — For allalternatives,each proposed ormarket-based
iki/CRS-RL30031major proposed andcumulativefinal major rule,mechanisms;final rules relatingcompliance burden,agencies mustflexibility provided to
g/wto human healthnet effect on smallanalyze incrementallocal and state
s.or
leakand thebusinesses, whethercosts governments and the
environment,benefits justifyand benefits of theregulated community;
://wikiagencies mustcosts, and whetherrule and alternatives and quality of
httpanalyze costs andgreater net information
benefits tobenefits or lower netFor each final major
governments andcosts are achieved;rule, agencies must
the private sector;also must describeanalyze whether
cost-effectivenesspersons who arebenefits are likely
of the rule andlikely to benefit andto exceed costs,
alternatives; andto bear the costand effects on small
whether benefitsbusinesses, net
justify costsemployment, and
cumulative financial
compliance burden
Principles ofNo provisionSpecifies principlesNo provisionSpecifies principlesNo provision
Economicof economic analysisof economic analysis
Analysis



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Mandates forS. 171 — AgenciesFor new majorFor all proposed orFor proposed andFor proposed and
Risk Analyses must analyze arules, majorfinal major rulesfinal major rules thefinal major rules the
rule’s effect onenvironmentaldesigned to protectprimary purpose ofprimary purpose of
health or thecleanup plans, andhealth, safety, orwhich is to addresswhich is to address
environment;reviews of existingthe environment,health, safety, orhealth, safety, or
estimate risk torules, agencies mustagencies mustenvironmental risk,environmental risk,
individuals; andanalyze risks, dataassess incrementalagencies mustagencies must
compare risks quality, andrisk reduction,analyze risk andanalyze risk to
incremental riskdistribution of risks,distribution of risk toexposed individuals,


S. 2019 —reduction, and mustknown substitutionexposed populations,populations, or
Agencies mustcompare risksrisks, andsubpopulations, ornatural resources,
analyze risks tocomparable risks natural resources,including
iki/CRS-RL30031human health, and must comparesubstitution risksincluding risks torisks when data are
g/wsignificant available
s.or
leaksubpopulations
disproportionately
://wikiexposed or parti-
httpcularly sensitive,
and compare risks
for at least 6 other
hazards

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Principles ofNo provisionSpecifies principlesSpecifies principlesSpecifies principlesSpecifies principles
Riskof risk assessmentof risk assessmentof risk assessmentof risk assessment
Assessmentand riskand riskand riskand
and Riskcharacterizationscharacterizationscharacterizationscharacterizations
Characterizati
onRisk analyses forAgencies mustAgencies mustAgencies must
major rules must beanalyzeanalyze uncertainties,analyze
plausible anduncertainties,variabilities,uncertainties,
realisticconflicting data,conflicting data,variabili-ties, and
and assumptions; beinferences, andassumptions;
For human healthscientificallyassumptions; consider reliable
risk analysis for aobjective andconsider “all relevant,and reasonably
iki/CRS-RL30031major rule, agenciesunbiased; and relyreliable, andavailable scientificmust use: the moston scientificreasonably availableinformation and
g/wscientificallyfindings andscientificpromote rational
s.or
leakplausible model;consider all relevantinformation”; beand informed risk
best estimates; andscientific dataobjective and management
://wikiprobabilisticsystematic, anddecisions and
httpdescriptions ofAgencies mustcarefully analyze theinformed public
uncertainty andexpress risk as aweight of theparticipation; and
variability; datareasonable range ofscientific evidenceprovide for public
must be developedestimates, includinginput to the process
in accord with -a best estimate; Agencies must revise
promulgated stan-distinguishassumptions toAgencies must
dards for toxicscientific findingsincorporate newexpress risk
substances andfrom otherrelevant and reliableestimates as
pesticide testsconsiderations andscientific informationreasonable ranges
for human healthas it becomesor probability
risk assessments,reasonably availabledistributions,
discuss conflictingincluding the most
dataAgencies mustplausible risk
express risk estimatesestimates for the
as reasonable rangesgeneral population



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
CertificationS. 171 — For eachNo provision For each final rule,For each major rule,No provision
final rule EPA mustan agency mustan agency must
certify that: thecertify that: certify: its
estimate andanalyses are basedcompliance with
analysis are basedon objective andrulemaking
upon “a scientificunbiased scientificprocedures and the
evaluation of theand economicsatisfaction of
risk” and supportedevaluation of alldecision criteria, or
by the “bestinformationan explanation of
available scientificprovided;why certification
data”; the rule willincremental benefitscannot be made
substantiallyare likely to justify
iki/CRS-RL30031increase health orand be reasonablyenvironmentalrelated to the
g/wprotection; and theincremental costs;
s.or
leakrule will produceand alternatives are
benefits that willeither less cost-
://wikijustify the costseffective or provide
httpless flexibility to


S. 2019 — Forregulated entities or
each proposed andlocal or state
final major rulegovernments
relating to human
health or the
environment, EPA
must certify that:
the analyses are
based on the “best
reasonably
obtainable scientific
information”; the
rule is likely to
significantly reduce

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
DecisionS. 171 — BenefitsPotential benefitsProhibits adoptionWhether a rule isNo provision
Criteria forwill justify costs justify potentialof a final rulelikely to be most
Rulescosts withoutcost-effective or to
S. 2019 — Likelycertification that—provide the greatest
benefits will justifyRule is the mostincremental benefitsnet benefits
costs, and rule iscost-effective orare likely to justify
most cost-effectiveleast-cost alternativeand be reasonablyWhether likely
alternative allowedrelated to thebenefits will justify
by lawRule does notincremental costs,costs
disapprove aand
product on the basisrule is most cost-
of safety if iteffective or
iki/CRS-RL30031presents a negligibleprovides morehuman risk underflexibility than
g/wintended conditionsalternatives
s.or
leakof use
Prohibits
://wikipromulgation of a
httpmajor rule unless
agencies have
complied with
analytic and
certification
requirements and
these are supported
by substantial
evidence of the
rulemaking record
Prohibits
promulgation of a
major rule without
OMB approval or



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Effect onS. 171 —ProhibitsRequires agenciesRequirements applyAdds new
ImplementatioCertificationpromulgation of ato consider analysesto the extent thatrequirements to
n of Existingrequirement doesrule unless decisionrequired bythey are notrulemaking under
Lawsnot amend, modify,criteria are met;Division C only “toinconsistent withexisting statutes and
or alter any statute decision criteriaextent permitted byexisting statutesapparently would
supplement existinglaw”supersede them if
S. 2019 — Doesstatutoryrequirements
not affect any otherrequirementsRulemakingconflicted
provision of federalprovisions of
law or authorizeNotice andDivision D
EPA considerationcommentsupersede
of additionalprocedures apply toprovisions of
iki/CRS-RL30031factors in itsrules under statutesexisting lawsdecisionsnot generally subjectauthorizing
g/wto 5 U.S.C. 553regulatory activities
s.or
leakdesigned to protect


Requires analysis ofhealth safety, or the
://wikian alternative to aenvironment
httpcleanup plan only if
it is consistent with
the agency’s
statutory authority
Supersedes laws
prohibiting or
denying approval of
a product on the
basis of safety if it
poses a negligible
risk to human health
under intended
conditions of use

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
ExecutiveNo provisionExecutive branch OMB may reviewOMB must establishNo provision
Coordinationmust developdraft and finala process to review
and Oversightuniform procedureseconomic analysesand coordinate
of Agencyfor regulatoryand rules; limitsagency regulatory
Analysesanalysis and overseetime for review toactions; limits time
agency90 days; OMBfor review to 90
implementation;must approve of, ordays, but allows
limits time forcomment on, finalextension
review of proposedeconomic analyses
or final regulationsfor major rules
to 30 days, which
may be extended
iki/CRS-RL30031President must issue with the Council ofSimilar to S. 343 OMB, in consultation
g/wguidance for riskEconomic Advisors
s.or
leakanalysis, and OMB(CEA), the Director
must issue guidanceof the Office of
://wikifor cost-benefitScience and
httpanalysisTechnology Policy
(OSTP), and relevant
agency heads, must
issue guidelines for
cost-benefit analyses,


Agencies mustrisk assessments, and
disclose changespeer review
Agencies mustmade from the
maintain apreliminary riskAgencies must
rulemaking fileanalysis in the finaldisclose changes to
containing copies ofregulatory impactregulatory proposals
all material thatanalysisthat result from
pertains directly toOMB review
the rulemaking that
was available to the

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
CongressionalNo provisionAgencies mustNo provisionNo provisionNo provision
Review ofsubmit final
Agencyregulations to
RulemakingCongress, which
may reject them by
joint resolution of13


disapproval
iki/CRS-RL30031
g/w
s.or
leak
://wiki
http
This provision was enacted by the 104 Congress in Public Law 104-121.13th

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Peer Review No provisionCovered agenciesAgencies must haveAgencies mustNo provision
must have uniformindependent,arrange for
peer reviewexternal peerindependent peer
procedures; peerreview programs;review by broadly
review panels mustreview panels mustrepresentative expert
include a balancedbe balanced and notgroups; panels must
group of expertsexclude those withadhere to agency
representing alla potential intereststandards and
interests and notin the outcome, ifpractices governing
exclude those with adisclosed, unless aconflicts of interest
potential interest insingle entity is
the outcome, ifaffected by aFederal Advisory
iki/CRS-RL30031disclosed, unless aregulatory decisionCommittee Act doessingle entity isnot apply to peer
g/waffected by aRequires peerreview
s.or
leakregulatory decision;review of risk
excludes peopleanalyses andRequires peer review
://wikiassociated witheconomic analysesof risk analyses and
httpgeneration of thefor major rules withcost-benefit analyses
work beingan impact of at leastof major rules likely
reviewed; requires$100 million, and ofto have an annual
reporting ofany analysis likelyeffect of $100 million
minority viewsto have a significantor more
impact on public
Federal Advisorypolicy decisions, ifAgency must publish
Committee Actordered by OMBa statement by a
(FACA) applies tofederal official from
peer review panelsA National Peeroutside the agency
Review Panel mustindicating that review
annually reviewparticipants were
agencies’ costindependent and
assessmentexpert and that the
practicesagency has



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Peer ReviewRequires peer
(cont.)review of: risk
analyses, cost-
benefit analyses, and
supporting data for
major rules and
reviews of rules; -
data supporting risk
analysis of cleanup
plans; quantitative
estimates of risk or
hazard used in
iki/CRS-RL30031regulations; entriesinto EPA’s risk
g/wdatabase; guidelines
s.or
leakfor cost-benefit
analysis; and regula-
://wikitions for the
httpconduct of risk
analysis and risk
characterization
DeadlinesS. 171 — NoSuspends judicialAgencies mayDuring the first 2Same as S. 981
provision and statutorypromulgate a ruleyears after
deadlines forprior to completingenactment, suspends
S. 2019 — Actionrulemaking untileconomic analysesstatutory and judicial
required to meet arequirements forrequired bydeadlines for
statutory or judicialregulatory analysisDivision C ifrulemaking for 6
deadline shall notare metanalysis conflictsmonths or until
be delayed with deadlinesrequirements for
regulatory analysis
are satisfied



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Review ofNo provisionAgencies mustDivision D —Agencies mustNo provision
Existing Rulesreview all existingAgencies may setreview existing major
major rules, rulespriorities andrules as necessary
that are inconsistentprocedures for
with this Act, andreview, revision,
rules designated byand repeal of major
the President;rules promulgated
existing rules wouldprior to the
terminate in 7 years, effective date of the
new rules in 5 years,Act
unless reviewed


iki/CRS-RL30031
g/w
s.or
leak
://wiki
http

Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
CitizenNo provisionCitizens mayCitizens mayNo provisionNo provision
Petitionspetition for judicialpetition for judicial
review of agencyreview of agency
analysis andcompliance with
certification of aDivision C analytic
rule’s impact onrequirements
small entities
Citizens also may
petition for:
issuance,
amendment, or
iki/CRS-RL30031repeal of any rule;amendment or
g/wrepeal of any
s.or
leakinterpretive rule,
guidance, or general
://wikipolicy statement; a
httpvariance or
exemption from any
major rule; cost-
benefit analysis of a
major rule; review
of a risk assessment
or cost-benefit
analysis for a major
rule or major
cleanup plan; and
review of any risk
assessment or any
entry on an agency-
developed database



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
ActionsS. 171 —Subjects to judicialDivision C —Permits judicialSubjects to judicial
Subject toCertification is notreview all agencySubjects agencyreview of agencyreview agency (but
Judicialsubject to judicialdecisions (and anyanalyses regardingcompliance withnot OMB)
Reviewreview; no cause offailure to make suchthe effect of a rulerequirements fordesignations of
action is granted todecisions) to issue,on small entities toregulatory analysisrules as major or
any persongrant, or deny rules,judicial review inonly in connectionnot major
orders, petitions, connection withwith review of a final
S. 2019 — Doeslicenses, sanctions,promulgation of aagency actionSubjects risk
not create any rightor relief major ruleassessments to
or benefit,Subjects to judicialjudicial review
substantive orSubjects to judicialDivision D —review agencies’when final rules are
procedural;review agencies’Subjects agencyregulatory flexibilityreviewed
iki/CRS-RL30031adequacy ofregulatory flexibilitycompliance withanalysis andcertification oranalysis andanalyticcertification
g/walleged failure tocertificationrequirements toregarding impact of a
s.or
leakcomply is notregarding impact ofjudicial reviewrule on small entities
grounds fora rule on smallunder the
://wikiinvalidating a majorentitiesauthorizing statute
httpruleand the
Administrative
Procedure Act



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Standard ofNo provisionWhether there isDivision D —Whether the cost-Whether the
Judicialsubstantial supportWhether agenciesbenefitdesignation of a
Reviewin the rulemakingsubstantiallydetermination, riskrule as major or
file for the factualcomplied with theassessment, or peernon-major clearly
basis of agencyprinciples for riskreview was whollyand convincingly is
actions, findings, orassessment andomittedshown to be
conclusions;characterization erroneous
whether agenciesWhether the final rule
observed proceduralis arbitrary,Whether the final
requirements;capricious, an abuserule is arbitrary or
whether statutoryof discretion, or iscapricious
authority wasunsupported by
iki/CRS-RL30031exceeded; orsubstantial evidenceWhether an agencywhether the agencywhere that standardfailed to perform a
g/winterpreted the ruleis otherwise providedrequired risk
s.or
leakin a narrow wayby lawassessment
when a broader
://wikiinterpretation would
httphave allowed the
agency to design a
rule with benefits
that justified costs
and that would be
more cost-effective
or less costly



Provision103 Congress104 Congress104 Congress105 Congress105 Congressrdthththth
Johnston Amendments,S. 343, as reported byH.R. 9, as passed by theS. 981, as reported S. 1728, as introduced
as passed by the Senatethe Judiciary CommitteeHouse
Risk-BasedNo provisionAgencies mustThe President mustOMB must contractNo provision
Prioritiesreflect risk-basedidentify relativewith a scientific
priorities in annualrisks and cost-institution to
budget requestseffective riskcompare risks to
reduction strategieshuman health, safety,
and opportunitiesand the environment;
and obstacles toto study
reflecting prioritiesmethodologies for
within regulatorycomparing dissimilar
programs to protectrisks; and to
health in a cost-recommend how to
effective and cost-set priorities for
iki/CRS-RL30031reasonable mannerreducing risks
g/wAgencies must use
s.or
leakthe results of the
study to inform their
://wikiannual budgets and
httpstrategic plans and
performance plans