Comments of the United States Government
on the
European Commission’s Better Regulation Package
The United
States welcomes the opportunity to provide comments on the European
Commission’s Better Regulations Package.
The Commission’s Action Plan for simplifying and improving its
regulatory environment, along with its companion communications on the
establishment of minimum standards for consultations and the definition of a
consolidated impact assessment, represents a constructive and noteworthy step. We support the Commission’s objective of
improving the quality of its regulations and making its regulatory process more
transparent. As a major economic and
political partner of the European Union (EU), the United States has a
substantial interest in EU regulatory activities. We are encouraged that the Commission is seeking public comments
on its draft Better Regulation Package and are pleased that all interested
parties have an opportunity to provide comments.
U.S.
comments focus on the companion documents to the Action Plan, which address
public consultations (Section I) and a consolidated impact assessment (Section
II). Before outlining our detailed
comments on the companion documents, we briefly wish to note our support for
two additional constructive elements of the Action Plan: 1) the creation of an
internal network under the Secretary General; and 2) the consideration of
alternative regulatory models.
·
The
creation of an internal network under the Secretary General for better
regulation is a constructive step. If
effectively implemented, this action could help facilitate a more consistent
Commission-wide approach to implementation and monitoring of the Action Plan,
and in particular, the implementation of Commission consultation procedures and
conduct of its impact assessments.
·
Promoting
the consideration of alternatives to legislation on a case-by-case basis (e.g.,
co-regulation, voluntary agreements) is an important step in achieving better
regulation. It is not clear, however,
how the Commission intends to provide guidance across the various parts of the
Commission for how alternative regulatory models are to be reviewed and
considered. Common criteria for
assessing the suitability of alternative regulatory tools would be helpful in
promoting a more uniform Commission-wide approach.
Additionally,
we support the Action Plan’s focus on “Developing a Common Legislative Culture
within the Union,” which addresses important improvements in transparency and information sharing currently under consideration
by the Commission, especially from the perspective of third countries. The Action Plan lays out steps for “creating
a legislative network between the institutions and the Member States,” to make
it easier to follow the progress of an act from its drafting by the Commission
to its adoption and application by the Member States. The stated purpose is to improve coordination and exchange of
this information between the Commission and national authorities.
·
The
status of Community legislation and regulation in relation to Member State
legislation/regulation, and which controls at a given point in time, is of
interest to all stakeholders. Once the
Commission and Member States have developed a joint approach to monitoring and
applying Community legislation, this information should be made publicly
available on the Internet.
I.
Communication on Consultations
We
strongly support the effort by the European Commission to make its consultation
procedures more transparent and consistent. The Commission’s document proposing
general principles and minimum standards for consultation (COM (2002) 277) is a
particularly positive step. Efforts to
promote transparency result in better quality regulations and greater public
acceptance of the resulting regulations.
We welcome the opportunity to provide comments on these draft principles
and minimum standards, and are encouraged that the Commission is seeking public
comments.
As noted in
the initial U.S. Government comments on the Commission’s White Paper on EU
Governance, we support the five key principles referenced in the Consultation
document: participation, openness, accountability, effectiveness, and
coherence. These principles are
consistent with U.S. efforts in bilateral and multilateral discussions to
promote good regulatory practices. They are also consistent with U.S. regulatory practice.[1]
We view the
Commission consultation document as a potentially significant contribution to a
more transparent and accountable EU regulatory process. In fact, it is key to meeting the goal of
developing better regulations that would have greater public acceptance. If fully implemented, these principles and
standards could promote a more transparent, more inclusive, and more
accountable process. That said, this
paper is clearly one part of an ongoing process within the EU and is also
consistent with the Commission's White Paper on EU Governance. While the document contains many positive
elements, from our perspective it also raises a number of important questions
and concerns that we would like to note.
Oversight
of Consultations:
We note
that the Commission’s principles and minimum standards for consultations are
not legally binding. Absent a legal
commitment, we question the following: 1) how the Commission
will ensure that common procedures for conducting consultations will be
comprehensively and consistently implemented across the Commission, 2) who will
oversee application of these minimum standards, and
3) how will problems of inadequate or improper application be addressed?
Scope of
Consultations:
We suggest
that the general principles and minimum standards should apply to all
Commission regulatory initiatives. In
our experience, we have found that rulemaking is improved by broadly applying public
notice and comment procedures since it helps ensure that all relevant
viewpoints and information are considered, resulting in more effective and
practical regulations. Towards these ends, the Commission should consider the
following questions: 1) what is the regulatory scope for application of these
principles and minimum standards, 2) are all regulatory activities to be
subject to these standards or only “major policy initiatives”, 3) if the scope
of application is limited in some manner, how is such a determination made, and
4) what is meant by consultation requirements under international agreements
being excluded, e.g., how does the Commission define such requirements and what
if such requirements overlap?
We
suggest that objective criteria be provided to guide determinations of whether an initiative
is “major.”
We note
that comitology procedures are exempt from these principles and minimum
standards. What is the rationale for
exempting this decision-making process from
these standards? We suggest that the
comitology process could significantly benefit from more transparent input from
outside experts and the public.
Who is
Consulted and How:
The
Commission states that it is “committed to consult as widely as possible.” The
document also notes different types of public consultations, such as “open”,
“focused” or “restricted”. These references suggest that in some instances the Commission
will continue to utilize a consultation process that is not fully open to all
parties. Clarification should be made
of the scope of the consultations.
We note
that references in the document to “relevant parties” or “target groups” also appear to
suggest that the Commission’s consultation process may not always be open to
all interested parties. How does the
Commission determine what is a “relevant party” or a “target group”? What are the criteria used to determine such
parties?
We also
note that the Commission states that the “method and extent of consultations
performed must therefore always be proportionate to the impact of the
proposal.” What are the criteria that the Commission would utilize for determining which
procedures to use? How does the
Commission gauge the proportionality of the impact of the proposal for the
purposes of determining the extent of consultation? What is the rationale for not always using
an “open” consultations process, and then supplementing an open consultation
process with “focused” procedures as the Commission views necessary?
The Commission notes
concern about the equitable treatment of all parties (and “proper balance”) in
a consultation process. To address that
concern, we suggest that the Commission simply let interested parties identify
themselves instead of the Commission pre-selecting the “relevant” parties or
“target groups” to consult.
What
recourse is available for those who feel excluded from the process? It is important to clearly identify the
recourse of stakeholders that feel their right to consult has not been upheld. For example, if a party feels a particular DG has not offered
opportunity to comment on a regulation or legislation, what is the central
authority to which it would complain or seek redress? Since the “internal network for better lawmaking” described in
the Action Plan will be coordinated by the Secretary General, the Secretary
General could possibly be the best place for stakeholders to lodge complaints
and seek redress. If not the Secretary
General, some other specific point of redress should be made explicit within
the final minimum standards that are drawn up.
In our
view, a meaningful consultation process requires full
transparency and openness to the participation of all interested stakeholders,
EU and non-EU alike.
Timeframe
for Consultations:
The
document’s six-week timeframe for public comments on regulatory proposals
provides a useful minimum threshold. We
note, however, that for effective consultation with a variety of stakeholders,
more time is often necessary. For
significant proposals in the United States, Executive Order 12866, Regulatory
Planning and Review, specifies a comment period of at least 60 days. For less important
proposals, a shorter comment period may be provided. Furthermore, we note that under the WTO
Agreements on Technical Barriers to Trade, 60 days is recommended for comment
on draft regulations. We urge the
Commission to consider extending the comment period from 6 weeks to 60 days.
Timing
of Opportunity to Submit Written Comments:
We support Commission statements that “effective
consultation requires consultations to start as early as possible. Interested parties should therefore be
involved in the development of a policy at a stage where they can still have an
impact on the formulation of the main aims, methods of delivery, performance
indicators, and, where appropriate, the initial outlines of that policy.”
Furthermore, as the communication observes, consultation at more than one stage may be
required. Likewise, providing
opportunity for written comment at more than one stage may be equally
necessary.
The value of the opportunity to submit written
comments depends on the stage in the decision-making process at which it is
provided.
U.S.
regulatory agencies informally consult with
interested parties and the public at large in the development of
proposals and sometimes publish advance notices of proposed rulemaking
requesting written submissions of information to aid in defining a problem and
identifying potential regulatory solutions.
Once the agencies develop a proposal, they issue notices of proposed
rulemaking, except in emergencies and other limited situations, typically
setting forth the details of the proposal, explaining the need
for the proposal, the rationale for the particular provisions of the proposal,
including why the agency believes that its proposal effectively addresses that need,
why the agency is proposing as much as it is, and why it is not proposing more,
or less, and why the agency believes that its proposal meets the applicable
statutory criteria, e.g., practicability, and the impacts of the proposal.
The
opportunity to comment serves several purposes. One is simply to educate the policymaker and inform the
public. A second is to critique the
basis for a proposal, challenging the agency’s interpretation of data and
research, analytical assumptions, analytical methodologies, factual findings,
policy judgments, and assessment of the impacts of the proposal. A third is to suggest specific changes to
the proposal and/or to provide supplementary and/or
alternative data and research.
Similar to the sequence of rulemaking
conducted by almost all U.S. regulatory agencies, an opportunity for written
comment would be most advantageously
timed if it were provided after what is believed to be the best option is tentatively selected. If only one opportunity to
comment is provided during policy development and if it comes before the
narrowing of options actively considered down to a single best option (and made tentative judgments about the coverage and level
of stringency of the requirements included in that option), commenters would
face a difficult choice about the most effective strategy in preparing their
comments. For instance, they may decide to guess which option might
ultimately be selected in the future and guess what supporting data, analyses,
and policy arguments it might give for favoring that option. They could then focus their available
resources on analyzing and commenting in detail on that one option, but in
doing so they would risk having focused on the wrong option. Alternatively, they may
decide to spread their resources out over multiple possible options and
provide general comments on each. If
the Commission were to provide an opportunity to comment at the stage of
decision-making which it has made tentative decisions, this would enable
interested parties and the public at large to focus their comments to the best
effect.
Information
Available to Aid Interested Parties and Public at Large in Preparing Written
Comments:
Interested
parties and the public at large should be provided with the following at the
beginning of the period of preparing and submitting written comments so they
can prepare relevant and effective comments:
·
The
full text of the draft regulation for comment, rather than simply a summary of
the issue.
·
An
explanation of the reasoning underlying the draft regulation. The elements of this explanation would
ideally include the need for the regulation, its aims, its anticipated impacts
(quantified where possible), its economic and technical feasibility, and
alternative regulatory options. It
would also include the Directorate General’s interpretation of the supporting information and its resulting tentative
findings of fact and policy judgments.
·
The
relevant research, data, and analysis relied upon in developing the draft regulation.
Comment
Process:
The
establishment of a single Commission access point for obtaining information on
all consultations and for making public comments is an especially useful
step. Such an effort could contribute significantly to
wider public participation in consultation proceedings.
It would be
useful if the Commission could clarify how it intends to manage public comments
received. Will there be a public docket
so that interested parties can review the public comments the Commission
receives on draft regulations? If so,
would this be the Commission’s “single access point” on the Internet? To the extent possible, all the materials
made available to the public should be placed on the
internet/world wide web so that all interested parties can have access to the
documents.
Disclosure of oral as well as written communications:
A broad disclosure policy would aid the
Commission in its policy making. If
interested parties know each other’s submissions to the Commission, they can
aid the Commission in sifting through and assessing the merits of competing or
uncertain studies, analyses and recommendations.
In addition, a broad disclosure policy
would increase credibility and perceptions of fairness. So
that interested parties and the public at large can assess whether all
participants are adequately and equitably treated in the development of
Commission proposals, the public should be given access to all non-trade secret
information and views from all non-governmental parties and persons, regardless of whether submitted during oral
consultations or during a written comment period. This would address the concern
that some parties and members of the public at large might have that there
might be “secret” channels of communication.
As the Commission observes: “the
processes of administration and policy-making must be visible to the outside
world if they are to be understood and have credibility.” To that end, the Commission should
memorialize in writing and make publicly available the non-trade secret
portions of all views, facts and arguments orally submitted by
interested parties and others.
Explanatory
Memorandum:
The
inclusion of the results of consultations in the explanatory memorandum is a
useful step. We have often found that
the Commission’s explanatory memorandum accompanying draft regulations are not
considered by the Commission to be public documents. We urge that the Commission ensure that all explanatory
memorandum be made public documents.
The
document notes that the “Commission will
encourage practices to provide adequate feedback to responding parties and the
public at large.” We note that an
“acknowledgement of receipt of contribution” may fall
far short of a commitment to substantively respond to public comments. How will parties that submit comments be
informed of how and why their views were (or were not) incorporated in the final
regulation? Providing greater
specificity as to how comments will be addressed would be helpful to all stakeholders.
We also
suggest that the memorandum list the most important issues raised in
consultations and explain how they were considered
and resolved. This explanation would impart several benefits. It would help provide a convincing demonstration
of the rationality of the decision-making process. If done with sufficient specificity, it would enable interested
parties and the public at large to “check that they are making an effective
contribution to a transparent, open and accountable system.” In order to achieve the goal of
demonstrating the equitable treatment of all participants, the explanations of
the response to comments and other results of consultation should explain
response to oral as well as written communications, whether from open or
focused consultations or other non-governmental sources.
The Action
Plan section on expanding Explanatory Memoranda states that explanatory
memoranda will include certain information “possibly on the basis of a standard
format”. We strongly support that the
format should be standardized to make it as easy as possible for interested
parties to review and understand the actions taken regarding any given
legislative proposal.
Ensuring consistent compliance with the minimum
standards:
We
believe that a single entity, e.g., the Secretariat General, should be given
the responsibility for monitoring and critiquing compliance with the standards,
periodically reporting on compliance, and making recommendations for improved
practices. Given
that the minimum standards would not be legally binding, assigning effective
oversight responsibility would be important for fully realizing the promise of
the minimum standards. The
single entity should also promote best practices in complying with the
standards, e.g., identify examples of best practices in the preparation of the
explanatory memoranda and post them to provide further guidance to the various
Directorate Generals.
Guidelines
for use of expertise:
Finally, we
support the Commission’s stated intention of developing guidelines on the use
of expertise, as a supplement to these consultation guidelines. We would encourage the Commission to provide
an opportunity for interested parties to provide public comments on such draft
guidelines.
II.
Communication on Impact Assessment
The U.S.
Government is also pleased to have the opportunity to offer comments on the
European Commission's Communication on Impact Assessment (COM (2002) 276). We believe Impact Assessment is a critical
component of the EC's Better Regulation Action Plan and, if implemented
carefully, promises to improve the quality of legislation and regulation
throughout the European Union.
We offer
the following comments based on the U.S. Government's experience in regulatory
reform. We recognize of course that
practices that have worked well in the U.S. are not necessarily appropriate in
the EU context and vice versa. However,
the comments below are generally consistent with previous reports by international
bodies on regulatory governance prepared by the OECD and other organizations.
Our
detailed comments focus on two main issues:
·
The
Communication would be strengthened by an articulation of underlying principles
of good impact assessment. Such
principles provide a framework for monitoring quality of assessments while
providing useful direction to analysts and policy makers. Principles are more general than the
technical guidance; and
·
The
Communication should provide for a stronger role for the Secretariat General in
overseeing and assuring the quality of impacts assessments, including their
consideration by policy-makers.
Integrating Secretariat General oversight into the day-to-day practice
of assessment and decision-making within the Commission will improve and assure
high quality analysis and utility for policy-makers.
1. The Need to Articulate Underlying
Analytic Principles
On page 7,
footnote 4, the Communication indicates that the "extended Impact
Assessment will follow the technical guidelines for impact assessment to be
issued ... in the autumn of 2002 and the general method as described in annex 2
of this Communication." It is thus
to these upcoming technical guidelines and the annexes to the Communication one
must turn for instructions on the development of an extended Impact
Assessment.
General Concern.
In large part, the annexes appear to call for descriptions, not analyses.
And, to the extent these annexes call for analyses,
they do not appear to articulate the underlying analytic principles the analyst
should follow to guide the recommendation of alternatives, or, in default
thereof, they do not appear to direct the analyst himself or herself to
articulate the underlying analytic principles upon which he or she based the
recommendation for the alternative supported by the Impact Assessment. We urge that the upcoming technical
guidelines clearly state the underlying analytic principles the analyst should
follow, or, in default thereof, clearly direct the analyst to articulate the
underlying analytic principles he or she followed in selecting a regulatory
alternative and reaching any other analytic conclusions.
Need to Articulate Underlying
Analytic Principles Clearly. Clearly articulated
underlying analytic principles that reflect the wider economic, social, and
environmental objectives underlying the assessment provide a framework for
analysis, as well as a basis for evaluating Impact Assessments. For example, in U.S. Executive Order 12866
(58 Federal Register. 51735, October 4, 1993), the U.S. Administration articulated
the regulatory philosophy that the Federal agencies should use in selecting
regulatory alternatives. "[I]n
choosing among alternative regulatory approaches, agencies should select those
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages; distributive
impacts; and equity), unless a statute requires another regulatory
approach." The President also
directed Federal agencies, when submitting a regulation for Executive review,
to include an explanation of how the regulation "avoids undue interference
with State, local, and tribal governments in the exercise of their governmental
functions." These statements of
underlying analytic principle direct agencies to balance social welfare and
avoid undue interference on other government jurisdictions in carrying out
their analysis to support a regulatory action.
More
specifically, for what would be our equivalent of an extended Impact
Assessment, Federal agencies were directed to assess the "benefits
anticipated from the regulation action (such as, but not limited to, the
promotion of the efficient functioning of the economy and private markets, the
enhancement of health and safety, the protection of the natural environment, and
the elimination or reduction of discrimination or bias) together with, to the
extent feasible, a quantification of those benefits." Federal agencies were also directed to
assess the "costs anticipated from the regulatory action (such as, but not
limited to, the direct cost both to the government in administering the
regulation and to businesses and others in complying with the regulation, and
any adverse effects on the efficient functioning of the economy, private
markets (including productivity, employment, and competitiveness), health,
safety, and the natural environment), together with, to the extent feasible, a
quantification of those costs." President Bush has instructed the Federal
agencies and OMB to continue to adhere to Executive Order 12866 in development
of impact assessments and our oversight of their quality.
Need to Articulate Underlying
Analytic Principles Supporting Underlying Policy Choices. As the annexes are currently written, substantial discretion
is given to the Directorate Generals in terms of allowing them to select the
framework, the issue and policy objectives, and the bases for evaluation. This means it is unclear how the objectives
to be identified by each Directorate General will be weighed against the
unstated wider economic, social, and environmental objectives that will drive
the conclusions in the analysis. Thus,
the impact assessment will not serve as "an aid to decision-making"
(p. 3) because the reader will have to infer the wider economic, social, and
environmental objectives supported by the impact assessment.
For
example, on page 12, in the "Problem Identification" for the
Preliminary Assessment Statement, the Communication calls for the analyst to
"indicate the potential inconsistencies between the three dimensions [of
unsustainable economic, social, and environmental trends] or with other
policies." For the analyst to
identify inconsistencies will require the analyst to assume an underlying
analytic principle upon which to base a comparison. But the Preliminary Assessment Statement neither states such an
analytic principle, nor asks the analyst to articulate the one he or she
selected in making the comparison.
On page 13,
in the discussion of "Analysing the Issue," the Communication states
that "the identification and analysis of the issue(s) in one or more
policy areas ... will be described in economic, social and environmental
terms." At page 18, the
Communication asks, "what is the issue/problem in a given policy area
expressed in economic, social and environmental terms including unsustainable
trends?" While this statement and
question instruct the analyst how to describe the issue, neither does this
statement provide for any underlying analytic principles nor does the question
call for the analyst to articulate those that he or she followed in preparing
the description.
On page 19,
under "Commission draft proposal and justification," the
Communication poses the ultimate analytical question, "what is the final
policy choice and why?" However,
annex 2 does not appear to offer any guidance on what criteria or underlying
analytic principles the analyst should follow in making this "final policy
choice" nor do the instructions call for the analyst to articulate the
underlying analytic principles he or she used in answering the question
"why." This leaves the reader
to guess what policy alternatives were considered, and what underlying policies
are favored by the analyst and thus furthered by the recommendations made.
Need to Articulate Underlying
Analytic Principles to Select the Analytic Tools for the Extended Impact
Assessment. This need for the Communication to provide
the analyst with underlying analytic principles, or, in default thereof, to
have the analyst articulate the underlying analytic principles he or she
adopted in carrying out the Impact Assessment, extends to the choice of
analytic tool to be selected.
For
example, on page 15, under "Assessing the impacts
("scoping")," the Communication points out that a "number
of analytical methods can be used to assess impacts ... e.g., cost-benefit
analysis, cost-effectiveness analysis, compliance cost analysis, multi-criteria
analysis and risk assessment. The
choice of method and the level of detail will vary with the nature of the
problem and judgements about feasibility." These different kinds of analysis call for different underlying
analytic principles, the selection of which may determine which kind of
analysis the Directorate General chooses to prepare. We recommend that the Communication articulate these underlying
analytic principles to assist the Directorate Generals in selecting the kind of
analysis that would most fully and appropriately assess the category of issue
involved.
This
ambiguity on the selection of analytic tools also extends to the Commission's
decision to prepare an extended Impact Assessment. On page 15, the Communication states that this decision will be
based, inter alia, on
"Whether the proposal will
result in substantial economic, environmental and/or social impacts on a specific
sector or several sectors, and whether the proposal will have a significant
impact on major interested parties;" and
"Whether the proposal
represents a major policy reform in one or several sectors."
We are concerned that the normative
standards in making this decision turn on ambiguous terms (e.g.,
"substantial," "significant," and "major") that,
like an accordion, constantly expanding and shrinking, leave wide discretion on
whether or not to prepare an extended Impact Assessment. Without an analytical framework, a
decision-maker cannot determine what is significant. In other words, these
decision criteria would become workable once they are embedded in an analytical
framework; otherwise, they are completely unworkable.
We suggest that the upcoming
technical guidelines add more objectively-based criteria to help guide the
Commission and the responsible Director Generals in deciding whether or not to
prepare an extended Impact Assessment.
For example, U.S. Executive Order 12866 included an objective decision
criterion to direct the preparation of an impact assessment, namely whether the
regulation may "have an annual effect on the economy of $100 million or
more." We have found that a
designated estimated economic impact or even a range of estimated economic
impacts removes much of the ambiguity that comes from more hortatory statements
of general policy.
Similarly, on page 8, the
Communication states that "the impact assessment will be conducted
according to the principle of proportionate analysis, i.e., varying the degree
of detail to the likely [i.e., anticipated] impacts of the proposal. This means
that the
depth of the analysis will be proportionate to the significance of the
likely [i.e., anticipated] impacts.
Thus, proposed measures that are likely to have serious negative side
effects or particularly affect certain groups in society should be more
thoroughly analysed than minor technical changes to regulations." We fully support this statement of
policy. This is an implicit economic
criterion -- marginal benefit justifying marginal cost. Again, however, we would suggest that the
upcoming technical guidelines provide more objectively measured criteria --
e.g., an estimated range of population, a number of social groups or member
countries affected, and a range of estimated economic impacts -- to help guide
the implementation of this principle of proportionate analysis.
Need to Articulate the Underlying Analytic Principles for Carrying out
the Extended Impact Assessment. Similarly, this need
for the Communication to provide the analyst with underlying analytic
principles, or, in default thereof, to have the analyst articulate the
underlying analytic principles he or she adopted in carrying out the Impact
Assessment, extends to the detailed analytic criteria the analyst should follow
in carrying it out.
On page 16, under "Assessing
the impacts ("scoping")," the Communication states that
"the economic, social and environmental impacts identified for the
proposed option should be analysed and presented in a format that facilitates a
better understanding of the trade-offs between competing economic, social and
environmental objectives. To show the
different impacts, make comparisons easier and identify trade-offs and win-win
situations in a transparent way, it is desirable to quantify the impacts in
physical and, where appropriate, monetary terms (in addition to a qualitative
appraisal)." On the reasonable
assumption that analytic issues may involve health, safety, or the environment,
the Communication, on page 19, further directs the analyst to answer the
question, "what are the results of any scenario, risk or sensitivity
analysis undertaken?"
We support these principles of
"scoping" and the questions posed, but they appear incomplete. Given the importance of health, safety, and
environmental issues and the importance and number of new ones that constantly
arise, we suggest that the upcoming technical guidelines articulate criteria to
provide transparency in the choice of analytic assumptions the analyst makes,
the methods of analysis he or she uses, and any uncertainties that can affect
the analyst's conclusions.
Similarly, the upcoming technical
guidelines should provide the analyst guidance on how scientific analysis
should be used in any extended Impact Assessment, and, more generally, on how
the analyst should assure the high quality of any data relied upon in
conducting the Assessment. For example,
in 1996 amendments to the Safe Drinking Water Act (42 United States Code
300g-1(b)(3)(A)), the United States Congress articulated basic standards of
quality for the use of science in decision-making by the Environmental
Protection Agency (EPA) on safe drinking water activities. EPA is directed, "to the degree that an
Agency action is based on science," to use "(i) the best available,
peer-reviewed science and supporting studies conducted in accordance with sound
and objective scientific practices; and (ii) data collected by accepted methods
or best available methods (if the reliability of the method and the nature of
the decision justifies use of the data)." Similarly, the United States Congress adopted a basic quality
standard for the dissemination of public information about risks of adverse
health affects. Under 42 United States
Code 300g-1(b)(3)(B), the agency is directed, "to ensure that the
presentation of information [risk] effects is comprehensive, informative, and
understandable." The agency is
further directed, "in a document made available to the public in support
of a regulation [to] specify, to the extent practicable -- (i) each population
addressed by any estimate [of applicable risk effects]; (ii) the expected risk
or central estimate of risk for the specific populations [affected]; (iii) each
appropriate upper-bound or lower-bound estimate of risk; (iv) each significant
uncertainty identified in the process of the assessment of [risk] effects and
the studies that would assist in resolving the uncertainty; and (v)
peer-reviewed studies known to the [agency] that support, are directly relevant
to, or fail to support any estimate of [risk] effects and the methodology used
to reconcile inconsistencies in the scientific data." More generally, we refer you to recently
issued "Guidelines for Ensuring and Maximizing the Quality, Objectivity,
Utility, and Integrity of Information Disseminated by Federal Agencies,"
67 Federal Register 8452, February 22, 2002.
In the absence of
underlying analytic principles, or, in default thereof, in the absence of an
articulation of the underlying analytic principles relied upon by the analyst,
the quality and usefulness of any extended Impact Assessment may vary
widely. And, absent the articulation of
such underlying analytic principles, there will be little basis against which
the Secretariat General or the public as a whole will be able evaluate the
quality of any specific extended Impact Assessment -- and thus seek to maintain and improve their quality and
usefulness over time.
2.
The Need in the Communication to Strengthen the Role of the Secretariat General
On pages 8-9, under
"Organisation of the extended impact assessment," the Communication
describes who in the Commission will be responsible to do what.
"Normally, the responsible
Directorate General will conduct the extended assessment informing the
Secretariat General and involving other Directorate Generals where these may be
affected by the proposal (using external expertise as appropriate)."
"In some cases, the Commission
may decide that, for the proposals with the most significant crosscutting
impact and the highest political importance, the DG responsible for the Impact
Assessment is assisted by, and normally chairs, an inter-departmental group
including the most concerned DGs and the SG. ..."
"While conducting the impact
assessment is the responsibility of the services in charge, the Secretariat
General will co-ordinate the basic support structure for the new impact
assessment procedures through the SPP/ABM cycle and its network, in particular
regarding the selection and monitoring of the proposals subject to extended
impact assessment. The Secretariat
General will co-ordinate the issuance of guidance documents, organisation of
training, exchange of good practice and will monitor the final quality of the
impact assessments carried out."
"The results will be presented
in an impact assessment report to be attached to the inter-service
consultation. This assessment will
replace existing assessments carried out by DGs, such as regulatory impact assessments,
business impact assessments, environmental impact assessment etc. (see 1.3),
now will be covered by the requirements for this category."
We applaud the consolidation of the
diverse impact assessments into a consolidated extended Impact Assessment, and
the fact that the Communication gives the Secretariat General an oversight
role. But we have concerns about
certain apparent weaknesses in this oversight role as it is set forth in the
Communication. With over 20 years of
experience in overseeing the impact assessments prepared by the various Federal
agencies, we want to suggest specific ways to assure more effective oversight.
Need for Ongoing, Day-by-Day Oversight.
We note that the Secretariat General "will monitor the final
quality of the impact assessments carried out." This implies that the Secretariat General will only review an
extended Impact Assessment after it has been written and formally submitted by
the responsible Directorate General. We
suggest that the quality of extended Impact Assessments will improve if staff
to the Secretariat General have the opportunity to review draft extended Impact
Assessments before they become final.
It is our experience that analysts are more willing to discuss analytic
issues cooperatively -- the clarification of possible ambiguities, the
consideration of additional alternatives, the articulation of underlying
assumptions and resultant ambiguities -- before completion, e.g., before formal
endorsement of the assessment by the analyst's institution, or before the
assessment is presented to the institution's overseer and the public for
official review.
The importance of such ongoing
oversight of the preparation of extended Impact Assessments further suggests
that the Secretariat General should designate a senior staff member to be responsible
for such oversight on a day-to-day basis, and provide that senior staff member
with a staff of analysts experienced in the development of impact
assessments. Only with such an ongoing
staff effort will the Secretariat General be able to "co-ordinate the
issuance of guidance documents, [provide for the] organisation of training,
[and assure the] exchange of good practice [between the responsible Directorate
Generals and others developing such extended Impact Assessments]."
Such ongoing, day-by-day oversight
by the Secretariat General would build and maintain the quality of the extended
Impact Assessments developed for use by the Commission. It will ensure greater consistency in
assumptions and techniques used in preparing analyses across Directorates. It
will minimize possible biases in analyses that may be inherent due to the
particularized perspectives of each Directorate and others preparing these
extended Impact Assessments. And it
will ensure the development of "best practices" to help all of those
developing extended Impact Assessments to improve and assure high quality
analysis and the most utility for policy-makers.
In addition to these comments, we
have provided copies of the following documents that provide useful material on
the U.S. approach to regulatory oversight.
1.
Presidential Executive Order 12866 -- Regulatory Planning and Review (58
Federal Register 51735, October 4, 1993).
Reaffirmed by the Bush Administration, this Executive Order lays out the
principles and procedures that govern centralized regulatory oversight in the
USA.
2.
U.S. Office of Management and Budget, Guidelines for Ensuring and
Maximizing the Quality, Objectivity, Utility, and Integrity of Information
Disseminated by Federal Agencies (67 Federal Register 8452, February 22,
2002). These recent OMB guidelines are
aimed at enhancing the quality of information -- including scientific and
analytic information -- which federal agencies disseminate to the public and
use in policy making.
3.
The Regulatory Flexibility Act of 1980, 5 United States Code chapter
6. The purpose of this statute is to
establish a principle that Federal agencies endeavor, consistent with the
objectives of applicable law, to fit regulatory and informational requirements
to the scale of entities subject to a regulation. To demonstrate this effort, Federal agencies are required to
solicit and consider flexible regulatory proposals, and explain the rationale
for their actions to assure that flexible regulatory proposals are given
serious consideration.
4.
U.S. Office of Management and Budget, Draft Report to Congress on the
Costs and Benefits of Federal Regulations, 67 Federal Register 15014, March 28,
2002. This draft report, now being
revised in response to public comment, describes recent regulatory reform
activities of the Bush Administration.
The final Report is expected to be released to Congress and the public
by late summer or early fall.
5.
U.S. Office of Management and Budget, "Economic Analysis of Federal
Regulations under Executive Order 12866" (January 11, 1996);
"Guidelines to Standardize Measures of Costs and Benefits and the Format
of Accounting Statements" (OMB Memorandum M-00-08, March 22, 2000). These documents are the technical guidance
that OMB provides federal agencies on how to perform regulatory impact
analysis. OMB is now in the process of
refining these guidance documents, a process that will take a year to complete
since it entails proposal, public comment, expert peer review, interagency
review and final release. Since the
Commision has indicated its intention to release its technical guidance on
impact assessment in the near future, we expect that these U.S. guidance
documents may be particularly useful.
[1] For example, the
concept of a meaningful opportunity to comment is one of the most important
concepts in our rulemaking process.
This concept “means that interested persons should be provided with an
opportunity to challenge the factual assumptions on which the agency is
proceeding and to show in what respect such assumptions are erroneous.” See American Bar Association “A Guide to
Federal Agency Rulemaking,” p. 197. The
concept means further that: 1) comments are invited from all interested parties
at an early stage, when changes or modifications can still be made; 2) timely
notice and availability to commenters and the general public of the key data,
analyses, assumptions and other information underlying the proposal; and 3)
written, reasoned agency response to the comments.