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Philip Morris

Legislative and Regulatory Aspects of Risk

Date: Sep 1991 (est.)
Length: 4 pages
2025546086-2025546089
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Author
Brown, D.R.
Type
REPT, REPORT, OTHER
Area
LOGUE,MAYADA/OFFICE
Document File
2025545619/2025546382/Harvard University Office of
Continuing Education Short Course Program Harvard School
of Public Health
Site
N426
Master ID
2025545673/6381
Related Documents:
Litigation
Stmn/Produced
Named Organization
Dept of Health
Sab
Request
Stmn/R1-072
Characteristic
EXTR, EXTRA
Date Loaded
24 May 1999
UCSF Legacy ID
blp02a00

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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.
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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
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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
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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.

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