1. REGULATORY SCIENCE
• UNIQUNESS • PROCESSES
• APPLICATIION
A. Alan Moghissi PhD
Institute for Regulatory Science
Potomac Institute for Policy Studies
George Mason University
moghissi@nars.org
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2. What is Regulatory Science?
• There are many individuals who have claimed that
regulatory science is not science. Regulatory science
is being contrasted with research science, academic
science, and many other similar terms.
•
• REGULATORY SCIENCE CONSISTS OF SCIENTIFIC
FOUNDATION OF POLICY NOTABLY REGULATORY
DECISIONS
• Included is scientific foundation of legislative and
judicial decisions.
• Decisions based on uncertain SI is common
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3. METRICS FOR EVALUATION OF
REGULATORY SCIENCE INFORMATION
• The process started at ~ 1978 by the
development of the concept of Best
Available Science (BAS); Metrics for
Evaluation of Scientific Claims were
derived from BAS leading to MERSI.
• Betty R. Love, Sorin R. Straja, Dennis K.
McBride and Michael S. Swetnam are
contributors to both BAS/MESC and
MERSI
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4. MERSI PRINCIPLES
• OPEN-MINDEDNESS PRINCIPLE Implies that
the scientific community must be open-minded
• SKEPTICISM PRINCIPLE requires that those
who make a claim must provide evidence
supporting the claim
• REPRODUCIBILITY PRINCIPLE Implies that a
claim is proven if anyone with the necessary
competency and tools can reproduce it.

5. MERSI PRINCIPLES
• Universal Scientific Principles: All
scientific disciplines use certain methods,
processes, and techniques in pursuit of
their professional activities. Also scientific
laws apply not only to a specific
discipline but to all scientific disciplines.
E.g. all scientific disciplines use specific
computational methods and apply the
rules of statistics in sampling, analysis,
and reporting their results.

6. MERSI PRINCIPLES
Transparency Principle: One of the primary reasons
for controversies associated with regulatory science is
the assumption of regulators and regulatory scientists
that the public is incapable of comprehending the unique
structure of regulatory science. If a scientific issue is
complex, it is the responsibility of regulatory scientists to
explain the subject to the public in a language that is
understandable to its recipients.
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7. PILLAR: CLASSIFICATION OF
SCIENTIFIC INFORMATION
• One of the primary reasons for the uniqueness
of regulatory science is the need to consider the
level of maturity of a regulatory science claim.
• Science evolves and new discoveries,
advancement of scientific knowledge, and
numerous technologies result from the evolution
of science.
• Therefore, it is necessary to classify scientific
information (SI) in terms of its level of maturity
and its reproducibility.

8. PILLAR: CLASSIFICATION OF
SCIENTIFIC INFORMATION
• Proven SI
• This class consists of scientific laws—
sometimes called scientific principles—and their
applications. The cornerstone of this class is
compliance with Reproducibility Principle
implying that any investigator who has the
proper equipment and the necessary skills can
reproduce it. Therefore, this class of SI does not
require assumptions or any other conditions for
its validity. This class also includes those applied
sciences that are entirely based on scientific
laws and that exclude assumptions.

9. PILLAR: CLASSIFICATION OF
SCIENTIFIC INFORMATION
Evolving SI
• The overwhelming scientific advances in virtually all
disciplines are Evolving SI. Virtually all regulatory
science information is included in this class.
• Reproducible Evolving SI: Reliable information
dealing with a subject that is not completely understood
constitutes the core of this class. This class of scientific
information is based on two attributes:
• This SI class complies with Reproducibility Principle
implying it is clearly and unambiguously reproducible by
those with appropriate skills and equipment.
• The scientific claim does not violate USP.

10. PILLAR: CLASSIFICATION OF
SCIENTIFIC INFORMATION
Evolving Science
• Partially Reproducible Evolving SI: Sometimes called
Rationalized Science, or Extrapolated Science, the key
characteristic of this class is that the scientific foundation
of information placed in this class is derived from Proven
Science or Reproducible Evolving Science but it uses
assumptions, extrapolations, default data, and other
processes in deriving its results and conclusions.
• This class includes a large number of SI used in
regulatory science. Whereas some of the regulatory
information placed in this category relies heavily upon
proven or Reproducible Evolving SI, others do less or
much less.

11. PILLAR: CLASSIFICATION OF
SCIENTIFIC INFORMATION
Evolving Science
• Association-Based Evolving SI: Sometimes called
correlation or observation studies, the information in this
class is not based on Proven SI or Reproducible
Evolving SI.
• Hypothesized SI: This class consists of an organized
response to an observation, an idea, etc.
• SI-Based Judgment: This class consists of decisions
without having the needed SI including basic principles,
the necessary data, and other scientific requirements.
• Speculation: This class consists of information that
cannot meet standards described in any of the above
classes.

12. PILLAR: RELIABILITY OF
SCIENTIFIC INFORMATION
• Personal Opinions:
• Expression of views by individuals regardless of their
training, experience, and social agenda, are included in
this group. In a free society, every individual has the
right to state an opinion regardless of the reliability of SI.
• Gray Literature
• This category consists of written information prepared by
government agencies, advocacy groups, and others that
has not been subjected to an independent peer review.
This is the favorite category of those who want to
promote an idea.

13. PILLAR: RELIABILITY OF
SCIENTIFIC INFORMATION
Independent Peer Review/Scientific Assessment
• Whereas Peer Review evaluates an exiting document
Scientific Assessment prepares a document.
• Scientific Assessment is common in regulatory science
• In both cases:
– Qualification of the Reviewers
– Their Independency ( Lack of Conflict of Interest)
– Review Criteria
– Oversight of the Process

14. PILLAR: RELIABILITY OF
SCIENTIFIC INFORMATION
Consensus Processed SI
• This category consists of SI intended to resolve
scientific disputes and is particularly useful in
regulatory science as, in most cases, regulatory
science information is at best Partially
Reproducible Evolving SI and includes
assumptions, judgments, default data, and
related areas.
• The process used for this category is identical to
that used for Independent Peer review

15. PILLAR: OUTSIDE THE PURVIEW
OF SCIENCE
• The inclusion of ideology, societal objectives, policy,
beliefs, faith, or any other non-scientific objective in
assessing the validity of SI in Outside the Purview of
Science . The scientific foundation of a policy is identical
if it is performed, let us say, in the U.S., Russia, China,
Saudi Arabia, Brazil or Cuba. In contrast, the conclusions
derived from science can be significantly different in
countries identified above.
• According to Ruckelshaus Effect “… all scientists should
make it clear when they are speaking as scientists— ex
cathedra—and when they are recommending policy they
believe should flow from scientific information.”

16. Assessment of Predictive Models
• Applied science: Models that are entirely based on
Proven Science or Reproducible Evolving science are
applied science.
• Primary Predictive Models: The foundation of a large
number of models used in Regulatory science Proven
Science or Reproducible Evolving Science, they also use
assumptions, judgments, and other tools to develop or
apply the model.
• Secondary Models: These models use primary models
as their foundation. They are likely to be Scientific
Judgment.
• Tertiary and Lower Models: These models use
secondary models as their foundation. These models are
at best Speculation or more likely Fallacious Information.

17. REGULATORY SCINCE ETHICS
Principle I: A scientific issue is settled when anyone with the
necessary scientific skills, required equipment, and facilities can
reproduce it.
Principle II: Those who prepare a regulatory science document must
provide to the affected community assumptions, judgments, and
similar parts in a language understandable to a knowledgeable non-
specialist.
Principle III: Regulatory science information must exclude societal
objectives thus violating the MERSI Pillar “Areas outside the
Purview of Science”.
Principle IV: Regulatory science information is only then acceptable if
it has been subjected to independent peer review and the review
criteria include compliance with principles I, II, and III of regulatory
science ethics.

18. EVOLUTION OF REG. SCI. AT US
AGENCIES
• Initial Phase: The agency is given
deadlines without having the needed SI
• Exploratory Phase: The agency attempts
to develop the process to live within the
requirements of MERSI
• Standard Operation: The agency
operates in accordance with requirements
of MERSI

19. EXAMPLES
• NAPAP
• The Stage of Reg. Sci. at the EPA
• The stage of Reg. Sci. at the FDA
• Response to questions from the audience