Safety claims

But how do lawn service providers themselves view such risks Applicators continue to claim publicly, of course, that their products are safe, including making the often-circulated and unverified claim that customers eating 300 cups of treated grass clippings would have consumed the equivalent toxicity of one cup of coffee. The structure of the applicator industry allows a tremendous diversity of firms, however, and differentially placed participants in the lawn chemical economy are differentially sanguine about health and safety claims made by the industry s public relations machine. 

Meier, Barry. (1990). Lawn care concern says it will limit safety claims. New York Times. New York June 30, 30. 

National Association of Attorneys General. (1993). Orkin Unsubstantiated safety claims for pesticides. National Association of Attorneys General, Consumer Protection Report 32. Washington, D.C. NAAG. 

Guerrero, Peter F. (1990). Lawn Care Pesticides Remain Uncertain While Prohibited Safety Claims Continue. In Statement of Peter F. Guerrero before the Subcommittee on... 

These comments are directed primarily at efficacy and do not tend to be applied to safety, unless a safety claim (e.g. drug A is less toxic than drug B) is to be made. With the routine evaluation of safety, where p-values are being used as a flag for potential concerns, we tend to be conservative and not worry about inflating the type I error. It is missing a real effect, the type II error, that concerns us more. 

Keywords System Safety Complexity Safety Analysis Software Engineering Formal Methods OF-FMEA Safety Claim Structure Safety Case Safety Assessment... 

Once the safety argument has been constructed and documented, it is analyzed for flaws according to whatever regulatory or assessment criteria happen to be in place in the application domain (whether the system is suitable for use). To support the assessor s reasoning an Assessment Plan is to be developed and maintained, which includes a Safety Claim Structure to be completed (compare section 5 of this presentation). 

Firm evidence in support of claims requires that the results of the confirmatory trials demonstrate that the investigational product under test has clinical benefits. The confirmatory trials should therefore be sufficient to answer each key clinical question relevant to the efficacy or safety claim clearly and definitively. In addition, it is important that the basis for generalisation. .. to the intended patient population is understood and explained this may also influence the number and type (e.g. specialist or general practitioner) of centres and/or trials needed. The results of the confirmatory trial(s) should be robust. In some circumstances the weight of evidence from a single confirmatory trial may be sufficient. 

In the fall of 2004, Dr. David Graham, an FDA employee concerned with drug safety, claimed that new pharmaceuticals on the market were not always sufficiently evaluated as to safety, that is, to side effects, or biochemical individuality. Add to this the adverse interactions that can occur when two or more drugs are taken. The same caution, of course, applies to natural as well as synthetic medicines. 

The risk analysis and evaluation will form the heart of the safety case. It is here where the argument and evidence is set out to justify the report s safety claims. This information is inextricably linked to the detail in the hazard register but in the safety case one has the opportunity for further explanation and elaboration. The hazard register typically has a formal structure to support cohesion and consistency between hazards. The fiee-form text of the safety case facilitates articulation and openness enabling us to support our argument with direct and indirect evidence. Essentially the text provides the necessary inference between the hazards, causes, controls and evidence that is needed to justify the argument. 

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