Comments on Risk

The NRC document calls for hazard identification, dose-response assessment, exposure assessment, and risk characterization. In an effort to place descriptive experimental toxicity results in a clearer perspective and place more emphasis on evaluation, this outline deviates slightly from the NRC document and calls for hazard evaluation, hazard extrapolation, exposure assessment and risk characterization. In addition, a few comments on risk acceptability are given. Exposure assessments have been adequately discussed elsewhere in this symposium and will be discussed here only as they relate to hazard identification, evaluation, extrapolation and risk characterization. 

Additional comments on risk assessment techniques appear later in this chapter under Recommended Reading. 

This past April, a retired teacher posted this comment on risk communication expert Peter Sandman s Guestbook on his web site www.psandman.com/gst2011. htm children. 

As a final comment on inadequacies of mathematical representations of risk, those who bear the risk are not necessarily those who receive the benefit. While unequal distribution of risk and benefit may not be fair, it is difficult to redress die incquily. 

Okrent, D 1980, Comment on Societal Risk Science 208, pp 372-375, April. 

CES (2002b) Comments on near final risk assessment report. Letter from Centre Europeen des Silicones, Brussels, 9 July. 

Federal Register. Scientific Bases for Identification of Potential Carcinogens and Estimation of Risk Request for Comments on Report, Federal Register, 44, 1979, pp. 39858-39879. 

Balderacchi M, Trevisan M (2010) Comments on pesticide risk assessment by the revision of Directive EU 91/414. Environ Sci Pollut Res 17(3) 523-528... 

Tamoxifen users present also a doubling incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE) (118 vs. 62 cases). This increase is similar to that seen with HRT. There are some aspects of this side effect that should be commented on to improve the management of women eligible for tamoxifen treatment and at risk for DVT (Goldhaber 2005). In the subanalysis of the Italian study (Decensi et al. 2005), the venous thromboembolism definition included DVT, PE, and superficial phlebitis. Most of the VTE that the authors reported were, in fact, cases of superficial phlebitis, whereas the admitted definition of venous thromboembolism excludes this entity. Such conceptual differences, together with differences in age and background characteristics between the four studies, can explain the diversity in the incidences observed. 

The Chairman of FDA s Advisory Committee commented on the risk of death from developing PPH. "We have had what 1 think appears to be a reasonable estimate of the risk of deaths from pulmonary hypertension. We need to understand clearly that if a million patients take this drug, at least a couple dozen of them will die annually as a result of this complication. That seems the best estimate. This is something that has to be weighed seriously." The appearance of heart valvulopathies in otherwise asymptomatic people in their thirties or forties was unexpected and caught patients and practitioners by surprise. Both fenfluramine and phentermine cause an increase in the amount of serotonin available in the body, which can cause cardiac valvulopathies. 

Environmental Protection Agency. 2000. EPA Region IX, letter to James Bacon, Program Manager for Chemical Demilitarization, Febmary 22. Re Comments on the Conceptual Site Model for JACADS Closure Risk Assessment. EPA ID TTO-570-090-001. San Francisco, Calif. Environmental Protection Agency. 

Some comments on dves Dyes can be a threat to both human health and environment. Focusing on the effect of dyes on human health, it should be pointed out that on exposure to an environment containing vapors of dyes, one would experience headaches and dizziness. After inhaling large portions of these vapors, limbs could get paralyzed and damage of the inner organs may take place. Nowadays, the risks associated with the use of such dyes have been widely recognized and many countries have posted many restrictions to their use. In Europe, the launch of a new standard called ISO 14000 has banned the import of all materials dyed with poisonous dyes. 

The Air Force scientists who direct the Ranch Hand study concluded, in 1997, that dioxin exposure is associated with increased risk of adult-onset diabetes,12 which is the only disease that they link to dioxin. In their most recent comment on the possible dioxin-diabetes link, the Air Force scientists state that the evidence for a connection is weaker in the data collected in the 1997 exams than in the data from the 1992 exams.131 doubt that... 

Russell, W.L. Comments on mutagenesis risk estimation. Genetics 92 sl87-sl94, 1979. 

I would like to ask for any further comments on that point because I don t think the financial community is going to take any of the risks that we are talking about. 

Estimate the steady state surface temperature above that of the air ambient assuming a rate of loss of heat of 10 W m 2 K 1, and comment on how this might affect performance in a polluted atmosphere. [Answers 1.5mm 60/rm 2.5K reduces risk of condensation on the glaze surface and so risk of flash-over ]... 

The Marsh Risk pamphlet continues on page 23 with comments on losses in petrochemical plants ... 

I will outline very briefly for you the guidelines, process and procedures used at Shell for risk assessment and risk response (30, (2 ). I will focus my comments on how we are beginning to deal, for example, with decisions concerning the acceptability of operating existing hazardous waste disposal facilities or when considering new waste handling facilities. 

The New England Journal of Medicine asked one of the panel members of the FDA Psychopharmacological Drug Advisory Committee, physician and epidemiologist Thomas B. Newman (2004), to comment on the results of the studies conducted in the controlled clinical trials to determine the risk of suicidality. He wrote,... 

Once included in Annex XIV, the manufacturers, importers, and/or downstream users of the affected substance must request authorisation. The application is directly submitted to ECHA, which forwards the dossier to its Committee for Risk Assessment (CRA) and its Committee for Socio-Economic Analysis (CSEA) to produce a draft opinion within 10 months of submission. Applicants and interested third parties receive an opportunity to comment on the draft, whereafter the now finalised opinion is forwarded to the Commission, the Member States, and the applicant. The Commission then decides on the authorisation request following the regulatory committee procedure,27 which gives the Council veto power, but only in the rare instances where it can muster a qualified majority against the Commission measure.28... 

The DG Sanco interviewees, in a comment to a draft of this article,13 claimed that the opinion cited was perfectly within [the] remit of SCHER and that the fact that the Commission may not have followed the SCHER conclusions speaks for. .. the clear separation of risk assessment and risk management However, both of the recommendations in the quotation above - on risk reduction and alternatives -clearly concern risk management, not risk assessment. Furthermore, the recommendations do not answer the three questions to SCHER that were formulated in the Terms of reference in the opinion. 

The opinions issued by SCHER are basically scientific peer reviews, similar to a longer referee report for a piece submitted to a scientific journal. Just like any peer reviewer would do, SCHER comments on the data used in risk assessments, especially on the lack or reliability of data as well as on methods, approaches and interpretations. Uncertainty of exposure and effects and factors conditioning uncertainty are discussed, often resulting in statements such as firm conclusions cannot be reached . 

The implementation plan prepared by the Department of Environmental Affairs and Tourism proposed that an interim expert group will be appointed by the Minister of the National Department of Environmental Affairs and Tourism to assess project proposals and bioprospecting applications and review requests for access. It is too early to make any comment on whether the review process is working because the procedures are not yet fully operational. There is no indication in the regulations as to how long the assessment of the application may take, especially as the applicant may be required to conduct a risk assessment. 

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