Philip Morris
Legislative and Regulatory Aspects of Risk
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- Brown, D.R.
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- 2025545619/2025546382/Harvard University Office of
- Continuing Education Short Course Program Harvard School
- of Public Health
- Continuing Education Short Course Program Harvard School
- Site
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- Master ID
- 2025545673/6381
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Legislative and Regulatc,ru •,s.pr,,r; of Ris?,
David P. Brown Sl'cl).
L Introduction;
The application of risk assessment at the state level a unique problelrl
due- to the pressure for rapid timely decisions, inlmediac7 of political fartC>rs
and the roles of state agencies. This hour will exT)lore rislt assessment at. the
state level as it is currently conducted in a IdeT:~ England state, Connecticut.
First the state regulatory situation v,7ill be drscribed showing that the
risk assessment process follows the guidelines set forth in the federal
programs. Perspective is provided as an overview of the process. This will
be followed by discussion of three risk assessnient problems currently under
discussion, dioxin in air standard, drinkinn '~%Tat?r standards and radon in
water standards.
III. Perspective
A. ~eparation of management from risk asse..~.ment.
D. Unique role of Departments of Health.
1. Regulatory i1(~Tt~fArs.
2. Interstate communication.
C. A differing view of uncertainty.
- D. Myth of reaulation,the Role of Good Scienc.e
1. It is believed that regulatory stand.ar ds rest or should rest on on a
s~;i,entific base. Thus if the regulations are good they must rest on good
sci,ence. Itfoiiows from the above that effort IiE::eds to be expended to assure
t11-at regulatlolls are-scientifically deknsiblp and credible to sustain pollution
control decisions. ( Pcirapilrased from foIltier head of SAB)
2. There are several myths arounrJ regul_+.ti;;n.; -,-I.nd the regulatory procYs,.
This is shown b~~ the interaction of scienc~: with politics as it relates to tliree
questions derived from the above and s-li:: ;hr that the level of
misundPrstandinb is unacceptably hl,71h.

3. l:fey questions about the process;
,.a. Is bad science responsible for b_y:i I e;5
u.1.~.fi.10ll ?
-b. Would improved precision in sciellc:-e ililpro?Ta regulation?
-c. Have review boards improved the process from a public health
perspective?
To reveal my bias at the outset. I would ans;r.rer LFrO to all of the above.
I I I. Background
A. Gharacteristics of "good 5ciencr°
1. Controlled studies
2. r alid methods
3. Identification of test substances
4. Verification of conclusions
->NB. Characteristics of good regulation
1. Complete analysis of the data
2. Determination of limitations
3. Plausibility of the conclusions
4: Timel7 decisions
C. Nature of the problem
1. Items number 4 in A and E~ above are in conflict
2. Not to decide is to decide
3. Public health is not compatible ~,nth v;Tjw-sures vrhile Waiting
, to decide. eg ALAR, ASBESTOS, RADON
D. perceived conflicts in rights
1. Individual vs corporat* rights
2. Articles IV and V of ttie Cotist,it.utioll
3. Economic realities
tJ
Q
N
~
E
E.,mmptes of interactions of science and policy ~
. ~
~
1. Poor science and good p`?lic,:.7
Chic,ridane Q
~
~
2. Poor science and poor policy

Asbestos
Alar
j. Good science and poor policy
Ethvlene dibromide
I;erLene
4. Good science and good policy
tvietlT7lene chloride
Most OP pesticides
Radon
F. Illustration of the need for risY, a~"~'~':IT1Ynt.
1. The typical environment{,l
2. The typical research protocol
3. Application of data to reduce unuertainty
r;I A state's approach to ground v:'ater contamination.
The assessment and mitigation of grC!un-a Vt atrr contamination which
aif etrts pri y ate drinking water is one of the most. difficult problems facing
i;h.e healtfi and environmental agencies, at the _;tate and local levels.
A primary aspect of the problem is the need tet nTakA an immediate rkr.Ision
to terminate potential exposures even though the cont~'tiTTin-ants, their act.ions
ZMd the levels of exposures are not4. nov:Tn. It is also important to
o acYnowledge that water is essential for habit.1.t;ilit}T of the home.
This leaves the health official z,ttith need t.) make adevision with less than
complete information. As a matter of principle tiTe:le decisions should be
health based and.Inust be protective of public health. The decisions should
al,io bs? defensible in the scientific sens?.
There is a fundamental difference in the goals of academic research and the
need to reach a policy position. An acaden11r. r~':=F-'afch?r who is

r.n.complete data correctly refuses to decide but waits for more data but this
is a decision a public health official needs t.> decid? t~ecause to wait is aa
decision in it self .
The decision needs to have the folloTwiIlg characteristics it must be
pf'otect'tve of the public health it must be tiniely, it should be accurate, an'd it
sb,ould comply with the regulations.
If there is no regulation the basis for these decisions is the general powers of
the commissioner to protect the public health. This was not working in
connecticut so the state set up a procedure ior h:-3.ndling the situations
It is important to also understand the scope of the problem. Over the l~t.sr
ten years Connecticut has had over 1400 ~::rells contaminated. These wells
served 300,000 people. Under these circum4t_tnces it is not possible to
Handle individual instances vrTith a risk asJe.JJnlent approach.
A joint program has ben developed betVveeeil t.he, departments of healttl
services and the Departments of environn7enfi,M protection. jtSTlfi.hin Health
Services the process involves two groups the tcy.;ic hazzards section wllich is
res'ponsible for risk assessment and the ;ivater supplies srctioli 'which is
responsible for correcting the problem.
The process is based on a statute within the Uept of environmental
protection. The bottled water law.
v'. The state Dio.xin standard
A. Criteria for standard
B. Legislatures role.
V'I. The %mter radon standard
A. Backgrourid radon data
B. Effect of th*) strict standard sett.ing process
It
VII. Sumrnary.
